Systems, devices, and methods for treating pelvic floor disorders

ABSTRACT

Disclosed are single-incision surgical procedures for treatment of urinary incontinence and/or pelvic floor disorders and related uses, devices, kits, and methods. Implants are also disclosed for use in the exemplary procedures. In certain embodiments, soft tissue anchors are used to anchor the surgical implants to obturator membranes of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior application Ser. No.12/728,852, filed on Mar. 22, 2010, which is a divisional of priorapplication Ser. No. 11/400,111, filed on Apr. 6, 2006, whichapplication claims the benefit of U.S. Provisional Application No.60/668,736, filed on Apr. 6, 2005, U.S. Provisional Application Nos.60/702,539 and 60/702,540, both filed on Jul. 25, 2005, and U.S.Provisional Application No. 60/715,362, filed on Sep. 8, 2005, thecontents of which are incorporated by reference herein in theirentirety.

BACKGROUND

Pelvic floor disorders are a class of abnormalities that effect thepelvic region of patients, and they afflict millions of women. Thepelvic region includes various anatomical structures such as the uterus,the rectum, the bladder, and the vagina. These anatomical structures aresupported and held in place by a complex collection of tissues, such asmuscles and ligaments. When these tissues are damaged, stretched, orotherwise weakened, the anatomical structures of the pelvic region shiftand in some cases protrude into other anatomical structures. Forexample, when the tissues between the bladder and the vagina weaken, thebladder may shift and protrude into the vagina, causing a pelvic floordisorder known as cystocele. Other pelvic floor disorders includevaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele,and/or urethrocele.

Pelvic floor disorders often cause or exacerbate female urinaryincontinence (UI). One type of UI, called stress urinary incontinence(SUI), effects primarily women and is often caused by twoconditions—intrinsic sphincter deficiency (ISD) and hypermobility. Theseconditions may occur independently or in combination. In ISD, theurinary sphincter valve, located within the urethra, fails to close (or“coapt”) properly, causing urine to leak out of the urethra duringstressful activity. In hypermobility, the pelvic floor is distended,weakened, or damaged. When the afflicted woman sneezes, coughs, orotherwise strains the pelvic region, the bladderneck and proximalurethra rotate and descend. As a result, the urethra does not close withsufficient response time, and urine leaks through the urethra.

UI and pelvic floor disorders, which are usually accompanied bysignificant pain and discomfort, are often treated by implanting asupportive sling or mesh in or near the pelvic floor region to supportthe fallen or shifted anatomical structures or more generally, tostrengthen the pelvic region by promoting tissue in-growth. Often,treatments of stress incontinence are made without treating the pelvicfloor disorders at all, potentially leading to an early recurrence ofthe stress incontinence.

Existing systems, methods, and kits for treatment typically applydelivery devices to position a supportive surgical sling into a desiredposition in the pelvic region. However, some of these systems andmethods require a medical operator to create multiple incisions anddeliver the implant using complex procedures. Moreover, many existingsurgical implants are not suitably sized or shaped to properly fitwithin a patient and treat pelvic floor disorders. Accordingly, medicaloperators and patients need improved systems, methods, and surgical kitsfor the treatment of pelvic floor disorders and/or urinary incontinence.

SUMMARY

The invention generally pertains to systems and methods to treat pelvicfloor disorders and/or UI through the use of a single incision surgicalprocedure. In a general single incision technique, the operator makes anincision in the vaginal wall of the patient and uses the single incisionas the entry way into the patient's pelvic floor region to provideimplants for supporting the urethra, bladderneck, and/or pelvic floor.As explained in more detail below, the single incision approach can beused to insert, position, tension, and secure the implant without theneed to make additional incisions in the patient. In practice, theoperator makes the single incision in the anterior vaginal wall of thepatient and dissects bilaterally to the inferior pubic ramus on eachside of the patient. The operator couples a surgical implant to adelivery device, and then guides the device through the single incisionand to a target tissue region within the retropubic space on a firstside of the pelvic region of the patient.

The implant is secured within the retropubic space by soft tissueanchors, tangs on the implant, or both. In some implementations, theoperator couples a first end of the surgical implant to the deliverydevice by first coupling the first end of the surgical implant to a softtissue anchor, and then coupling the soft tissue anchor to the deliverydevice. The operator then secures the soft tissue anchor to the targettissue region and withdraws the delivery device, leaving the first endof the implant anchored to the target tissue region. In otherimplementations, the surgical implant is directly coupled to thedelivery device, and includes tanged end portions that secure to thetarget tissue region. The operator then repeats this process on a secondend of the implant to anchor the second end to a target tissue region toa contra-lateral location in the patient's retropubic space. In certainembodiments, the target tissue regions are located in the obturatormembranes of the patient and the implant supports the urethra and/orbladderneck of the patient.

In some configurations, the operator delivers implants that also extendto regions of the pelvic floor that are posterior to the bladderneck,and provides support to anatomical organs such as the bladder. In orderto provide implants that provide both anterior and posterior support,the implant is secured to a plurality of target tissue regions on eachside of the patient via a plurality of anchors or tanged portions oneach side of the implant. In these configurations, the operator repeatsthe above-described process for each of the anchors or tanged portions.After delivering the implant to the patient's retropubic space, theoperator may tension the surgical implant using a tensioning toolinserted through the vaginal incision. The systems and methods includesurgical implants, soft tissue anchors that anchor the surgical implantsto a desired anatomical location, delivery devices and methods thatdeliver the anchors and implants through the single incision to desiredanatomical locations, and tensioning devices that reposition and/ortension the surgical implants after delivery.

In one aspect, the systems and methods include surgical implants thatare sized, shaped, and constructed to treat a variety of pelvic floordisorders. In certain embodiments, the implants are slings that areconfigured to extend under the urethra and/or bladdemeck of the patientfor the treatment of urinary incontinence. In other implementations, theimplants are larger and configured to extend to and support regionsposterior to the patient's bladderneck, including the base of thepatient's bladder or further toward the posterior region of the pelvicfloor to support other organs.

In certain embodiments, the systems and methods include surgical implantassemblies for pelvic floor repair and/or for treatment of urinaryincontinence in a patient. An exemplary assembly includes a surgicalimplant having a first end, a second end, and a central region adaptedto extend to a position posterior to the bladderneck of the patient, andat least one soft tissue anchors coupled to an end of the surgicalimplant and adapted to secure the implant within the patient's pelvicfloor. In certain embodiments, the implant has a first end adapted toextend to a first obturator membrane, a second end adapted to extend toa second obturator membrane, and first and second soft tissue anchorsfor coupling to respective ones of the first and second ends of thesurgical implant and for securing to respective first and secondobturator membranes. The implant, in various embodiments, is sized andshaped to support anatomical structures within the pelvic region such asthe urethra, bladderneck, bladder, and uterus. The implants, in certainconfigurations, have anterior-to-posterior widths that allow the implantto extend to posterior regions of the pelvic floor region, includingregions posterior to the bladderneck and, in some configurations,posterior to the bladder.

The implant can couple to the soft tissue anchors in a variety of waysbased at least in part on the target tissue region where the implantwill be secured. In certain configurations, the implant directly couplesto and physically contacts the soft tissue anchors. In others, theimplant couples to soft tissue anchors by filaments which space the softtissue anchors away from the implant. The orientation of the mesh withrespect to the anchors may be varied to tension or loosen the implant.

An exemplary surgical implant for use with the systems and methodsincludes a first set of strands and a second set of strands separatefrom the first set of strands. The first set of strands and the secondset of strands are fixedly attached at a plurality of attachment points.An exemplary manufacturing technique includes extruding a first set ofstrands in a first direction, extruding a second set of strands in asecond direction different from the first direction, and attaching thefirst set of strands and the second set of strands at attachment points.

In one aspect, the systems and methods include implantable surgicalsling assemblies for pelvic floor repair and/or for treatment of urinaryincontinence in a patient. An exemplary implantable surgical slingassembly includes an implant for extending at least partially between afirst obturator membrane and a second obturator membrane of the patient.The implant has a first strap end for aligning with the first obturatormembrane, a second strap end for aligning with the second obturatormembrane, a first plurality of soft tissue anchors for coupling to thefirst strap end of the implant and for securing the first strap end to afirst soft tissue region, and a second plurality of soft tissue anchorsfor coupling to the second strap end of the implant and for securing thesecond end to a second soft tissue region. In certain embodiments, thefirst and second soft tissue regions are obturator membranes.

In another aspect, the invention includes implantable surgical slingassemblies for pelvic floor repair and/or for treatment of urinaryincontinence in a patient. An exemplary implantable surgical slingassembly includes a surgical implant having a first end for securing toa first obturator membrane of a patient and a second end for securing toa second obturator membrane of a patient. The assembly includes a firstset of at least three soft tissue anchors for coupling to the first endof the implant and for securing to the first obturator membrane, and asecond set of at least three soft tissue anchors for coupling to thesecond end of the implant and for securing to the second obturatormembrane.

The systems and methods also include sling end terminations that mayoptionally also be soft tissue anchors. In one aspect, the inventionincludes surgical sling assemblies for pelvic floor repair and/or fortreatment of urinary incontinence in the patient. An exemplary assemblyincludes a surgical sling for supporting at least one of a urethra and abladderneck of the patient, and a sling housing physically contactingand disposed about an end of the sling. The sling housing includes anaperture and tapers away from a distal end of the sling. In one feature,the sling housing is flexible. The aperture may be a ring, and thehousing may include legs extending radially from the ring. In oneapplication, the ring couples to a delivery device, and the legs engagewith and anchor to soft tissue.

In another aspect, an exemplary manufacturing technique for an implantis provided, comprising providing a mesh material, coupling the meshmaterial to a mold, injecting a curable material into the mold, allowingthe curable material to cure, and removing the mesh material from themold. The mesh material may have a pre-selected number of strands or apre-selected length, width and/or thickness to allow the manufacture ofa suitably sized implant.

In another aspect, surgical techniques are disclosed for delivering animplant to a patient. In one implementation, the techniques include asingle incision method for implanting a surgical implant in the pelvicfloor region of a patient for pelvic floor repair. The exemplary methodincludes the steps of creating an incision in the vaginal wall of thepatient, coupling the implant to a delivery device, inserting thedelivery device through the vaginal incision via the external vaginalopening of the patient, and implanting and securing the implant withinthe pelvic floor region of the patient such that at least a portion ofthe sling extends to a position posterior to the bladderneck of thepatient. The implant may be coupled to soft tissue anchors that anchorinto respective soft tissue regions, such as obturator membranes, of thepatient, and may additionally or alternatively include tanged portionsthat secure the implant to the soft tissue regions. The methods mayoptionally include tensioning the implant. In one feature, the methodsinclude coupling the implant to a delivery device having a shaft and aslidable cannula disposed about the shaft, inserting the delivery devicethrough the external vaginal opening, inserting the delivery devicethrough the vaginal incision subsequent to inserting the delivery devicethrough the external vaginal opening, aligning the shaft with a firstobturator membrane, sliding the cannula distally along the shaft, andsecuring the implant to the first obturator membrane.

In another aspect, the surgical implants are delivered through a singlevaginal incision and are secured to the patient's obturator membranes.In particular, according to an illustrative technique, an operatorcreates a single incision in a vaginal wall of the patient, couples theimplant to one or more soft tissue anchors, couples a soft tissue anchorto a delivery device, delivers the soft tissue anchor to an obturatormembrane via the single vaginal incision, and anchors the soft tissueanchor to the obturator membrane. The operator repeats this process forany other anchors used, including an anchor for the patient'scontra-lateral side, while using the same vaginal incision to insert theanchors and the implant. Either during delivery or subsequent todelivery, the operator optionally tensions the surgical implant. In oneaspect, the implant is adjustably coupled to one or more soft tissueanchors, and the operator tensions the surgical implant by adjusting theimplant's orientation with respect to its soft tissue anchors.

In certain implementations, a method is provided for treating urinaryincontinence in a patient. The method includes providing an implanthaving at least one tanged portion formed as a unitary body with theimplant, creating an incision in the vaginal wall of the patient,coupling an implant to a delivery device, inserting the delivery devicethrough the incision in the vaginal wall via the external vaginalopening of the patient, guiding the device to a location beneath thepatient's epidermis, and securing, by the at least one tanged portion,the implant to the patient's soft tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages will be more fully understood bythe following illustrative description with reference to the appendeddrawings, in which like elements are labeled with like referencedesignations and which may not be drawn to scale.

FIG. 1A shows a lateral view of the female pelvic region and anexemplary positioning of a surgical implant.

FIG. 1B shows an oblique view of the pelvic region and surgical implantof FIG. 1A. FIG. 1C shows an anterior view of the pelvic region andsurgical implant of FIG. 1B.

FIG. 2A shows a surgical implant having a central region and sixextensions.

FIG. 2B shows the surgical implant of FIG. 2A having tanged portions onits extensions.

FIG. 3 shows a surgical implant having a circular central region andfour extensions.

FIG. 4 shows a rectangular surgical implant sized and shaped for pelvicfloor repair.

FIG. 5 shows a trapezoidal surgical implant sized and shaped for pelvicfloor repair.

FIG. 6 shows a surgical implant that includes a plurality of aperturesfor promoting tissue in-growth.

FIG. 7A shows a surgical implant having a first set of strands and asecond set of strands attached at intersection points.

FIG. 7B shows a close-up view of the surgical implant of FIG. 7A.

FIG. 8A shows the implant of FIG. 7A with narrowed tanged portions. FIG.8B shows a close-up view of the implant of FIG. 8A.

FIG. 9 shows an implant having tanged portions that include a singlelong strand and a plurality of short strands.

FIG. 10 shows an implant having long strands and short strands, whereinthe long strands are oriented at a non-perpendicular angle with respectto the short strands.

FIG. 11A illustrates an exemplary extrusion technique for constructing asurgical implant similar to the surgical implant of FIG. 10.

FIG. 11B is a block diagram showing the steps of the exemplary techniqueillustrated in FIG. 11A.

FIG. 12 illustrates a surgical implant having three sets of strandsattached to each other at intersection points.

FIG. 13 illustrates a surgical implant manufactured using a similarmethod as in the surgical implant of FIG. 7A, but having a longeranterior-to-posterior length.

FIG. 14A illustrates a circular surgical implant including a first setof strands and a second set of strands attached at intersection points,wherein the implant is sized and shaped to extend to posterior regionsof the pelvic floor and to support anatomical structures such as thebladder.

FIG. 14B shows the surgical implant of FIG. 14A after selective removalof portions of the surgical implant.

FIG. 15A shows an implant shaped to interfit below a urethra orbladderneck of a patient.

FIG. 15B shows a clip used to shape the implant of FIG. 15A.

FIG. 16A shows a sling assembly including an implant and endterminations for associating the implant to a delivery device and foranchoring the implant to soft tissue.

FIG. 16B illustrates an exemplary manufacturing technique of the implantof FIG. 16A.

FIG. 17 shows an alternative configuration for an end termination havinga top piece and a bottom piece.

FIG. 18 shows an implant assembly including an implant and two endterminations, wherein each end termination includes a ring and no legs.

FIG. 19A shows a flexible end termination in a collapsed state.

FIG. 19B shows the end termination of FIG. 19A in an expanded state andinterfitted with a shaft of a delivery device.

FIG. 20 shows an implant assembly including an implant and twoalternative tab-shaped end terminations.

FIGS. 21A-D show exemplary barbed soft tissue anchors.

FIG. 21E shows a barbed anchor coupled to a portion of a surgicalimplant and anchored to an obturator membrane.

FIG. 22A shows a soft tissue anchor with a smooth outer surface andwithout barbs. FIGS. 22B-22C illustrate an exemplary technique for usingthe anchor of FIG. 22A to anchor a surgical implant to an obturatormembrane.

FIG. 23 shows a soft tissue anchor shaped like an arrowhead.

FIG. 24 shows the implant of FIG. 2A and depicts alternative approachesto couple soft tissue anchors with straps of the implant.

FIG. 25A illustrates a surgical implant coupled with soft tissue anchorsvia elastic rings. FIG. 25B shows the elastic rings of FIG. 25A instretched states.

FIG. 26A shows an implant assembly including a surgical implant thatcouples with soft tissue anchors via filaments.

FIG. 26B shows the implant assembly of FIG. 26A anchored within thepelvic region of a patient.

FIGS. 26C-D show an exemplary technique to tension the implant of FIG.26A.

FIG. 26E shows a corner of the implant of FIG. 26A after an exemplarytensioning technique.

FIG. 26F shows the implant assembly of FIG. 26B anchored within thepelvic region of a patient after tensioning.

FIG. 26G shows an exemplary technique for loosening the implant of FIG.26A.

FIG. 27 shows a delivery device having a movable shaft and a fixedcannula for delivering an implant assembly to the pelvic region of apatient.

FIG. 28 shows a delivery device having a fixed shaft and a moveablecannula for delivering an implant assembly to the pelvic region of apatient.

FIG. 29 shows the delivery device of FIG. 28 in an extended state.

FIG. 30 shows the delivery device of FIG. 28 having increment markingson its shaft.

FIG. 31A illustrates a transobtural single vaginal incision procedurefor delivering an implant sized and shaped to extend posterior to thebladderneck and support the base of the bladder.

FIG. 31B shows a transobtural single incision procedure similar to theprocedure depicted in FIG. 31A, for delivering an alternative implantsized and shaped for supporting the urethra and/or the bladderneck.

FIGS. 32A-32C show a delivery device including a handle and a curvedhalo-shaped shaft.

FIGS. 33A-B show symmetric delivery devices similar to the device ofFIGS. 32A-C, but having the curved shaft lie in a plane that isnon-orthogonal to a plane of the handle.

FIG. 34A shows an exemplary technique for delivering an implant sizedand shaped to extend posterior to the bladderneck and support the baseof the bladder using a transobtural single vaginal incision procedure.

FIG. 34B shows aspects of a transobtural single incision proceduresimilar to the procedure depicted in FIG. 34A for delivering analternative implant sized and shaped for supporting the urethra and/orthe bladderneck.

FIG. 35A shows aspects of a transobtural single incision procedure fordelivering a tanged implant without soft tissue anchors.

FIG. 35B shows aspects of a transobtural single incision proceduresimilar to the procedure depicted in FIG. 35A for delivering an implantsized and shaped to treat pelvic floor disorders.

FIG. 36 shows an exemplary placement of a surgical implant with strapssecured to target tissue regions of obturator membranes, levator animuscles, and sacrospinous ligaments.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The invention generally pertains to systems and methods to treat pelvicfloor disorders and/or UI by using single vaginal incision surgicalapproaches to deliver surgical implants to the patient's pelvic floorand/or sub-urethral and retropubic space. The implants are secured tosoft tissues within the patient's retropubic space by tanged portions ofthe implant, by one or more soft tissue anchors coupled to the implant,or both. The illustrative devices, systems, and methods of the inventionare described below in the following order. First, surgical implantssized, shaped, and constructed for treating UI and/or pelvic floorrepair are described. Second, soft tissue anchors are described that, incertain embodiments, secure the surgical implants to a desiredanatomical location, such as obturator membranes, along with methods forcoupling the soft tissue anchors to the surgical implants. Third,devices are described for delivering the anchors and implants to desiredanatomical locations in the patient's retropubic space, such asobturator membranes, along with tensioning devices and methods thatreposition and/or tension the surgical implant after delivery. Fourth,exemplary methods are described for implanting and positioning andsecuring exemplary implants within a patient's pelvic region by use of asingle vaginal incision surgical technique.

First, surgical implants sized, shaped, and constructed for treating UIand/or pelvic floor repair are described. The surgical implantsdescribed herein are adapted to be secured within the patient'sretropubic space. The implants support anatomical structures in thepelvic region and more generally strengthen tissue of the pelvic region.In one aspect, the surgical implants physically support anatomicalstructures in the pelvic region by providing physical hammock-likesupport to anatomical structures such as the urethra, the bladderneck,the bladder, the uterus, and other vessels and structures. In order tophysically support an anatomical structure, the surgical implants aresized and shaped to support that anatomical structure. In anotheraspect, surgical implants indirectly strengthen surrounding tissue bypromoting tissue in-growth. The surgical implants can be constructed toinclude apertures or interstices in which tissue in-growth can occur, ormay otherwise be constructed of a material that promotes tissuein-growth. Thus, surgical implants may be sized, shaped, and constructedto support anatomical structures and strengthen the tissue of the pelvicregion.

Turning to the Figures, FIGS. 1A-1C show an exemplary surgical implant 2that is positioned within the pelvic region 1 of a patient and securedtherein through the use of the procedures described herein. FIGS. 1A-1Cshow the surgical implant 2 having lateral edge 2 a, anterior edge 2 b,and posterior edge 2 c, and being sized, shaped and positioned tosupport the urethra 4, the bladder 6, and the bladderneck 5 (the regionthat adjoins the urethra 4 and the bladder 6), of the patient by softtissue anchors 20 a-20 f. In particular, FIG. 1A shows a lateral viewand FIG. 1B shows an oblique view of the pelvic region 1. As shown, theimplant 2 is located in the tissue region directly below the urethra 4and the bladderneck 5 with the soft tissue anchors 20 a-f anchored intothe patient's obturator membranes, the lateral edge 2 a located on oneside of the urethra 4, bladderneck 5, and bladder 6, and the anterioredge 2 b located under the urethra 4 to help strengthen this tissueregion in part to treat UI and/or urethrocele. The posterior edge 2 c ofthe depicted surgical implant 2 also extends to a location that isposterior 12 to the bladderneck 5, to support the tissue near theposterior region 6 a of the bladder 6 and the inferior region 8 a of theuterus 8 to assist in treating other pelvic floor disorders includingcystocele, uterine prolapse, enterocele, rectocele, and/or vaginalprolapse. However, because the various tissue regions of the pelvicregion are interconnected, strengthening one tissue region often treatsdisorders afflicting other tissue regions.

FIG. 1C shows an anterior view of the pelvic region 1 with the anterioredge 2 b of the implant 2 as described above. The exemplary surgicalimplant 2 forms a hammock-like support below the urethra 4, thebladderneck 5, and the bladder 6. The surgical implant 2 is held inposition by the six soft tissue anchors 20 a-f that anchor to respectiveobturator membranes 22 a and 22 b with three such anchors on each side.An obturator membrane is a thick fascial membrane and is locatedlaterally on either side of the pelvic region. The obturator membrane isa convenient supporting structure for soft tissue anchors, such as softtissue anchors 20 a-f, in part because it is strong, and in part becauseit is large and thus provides lateral, anterior, and/or posterioranchoring locations (in fact, the obturator membrane spans the obturatorforamen, the largest foramen in the skeleton).

In the depicted embodiment, the anchors 20 a-f couple to surgicalimplant 2 and anchor directly into the obturator membranes 22 a and 22b. However, in alternative embodiments, the anchors 20 a-f anchor intomuscle tissue located laterally beyond the obturator membranes 22 a and22 b. In other embodiments, the implant 2 does not span the full lengthbetween the obturator membranes 22 a and 22 b, known as theobturator-to-obturator length, but instead couples to the anchors 20 a-fvia filaments or rings that space the implant 2 away from the anchors 20a-f and anchor into the obturator membranes 22 a and 22 b. In stillother embodiments, the implant 2 does not anchor to the obturatormembranes 22 a and 22 b, but instead anchors to other soft tissueregions in the retropubic space, such as the region of the tendinousarch of the levator ani muscle, as discussed below.

The implant 2 may be sized and shaped to achieve a desired patient fit.FIG. 2A shows an illustrative surgical implant 30 of the type shown inFIGS. 1A-C having a trapezoidal shaped central region 30 a and sixextension straps 32 a-f. In other embodiments the central region 30 a isrectangular. In certain embodiments, the implant 30, including straps 32a-f, spans at least a length 34 that extends between or beyond a firstobturator membrane and a second obturator membrane of the patient, alsoknown as the patient's obturator-to-obturator length. Thus, when thestraps 32 a-f are delivered via the single vaginal incision, the straps32 a-c attach to a first obturator membrane either directly or via softtissue anchors directly coupled to the straps 32 a-c, and straps 32 d-fattach to the contralateral obturator membrane either directly or viasoft tissue anchors directly coupled to the straps 32 d-f, asillustrated with respect to Figures A-C.

In alternative implementations, the straps 32 a-f are secured to othertarget tissue regions in the patient's retropubic space, such as thepatient's sacrospinous ligaments or levator ani muscles. By way ofexample, straps 32 a and 32 d may extend to target regions of thesacrospinous ligament, straps 32 b and 32 e may extend to target regionsnear the tendinous arch of the levator ani muscle, and straps 32 c and32 f may extend to target regions of the obturator membranes. Each ofthe straps 32 a-f may have varying lengths in order to reach theirrespective target tissue regions.

In certain embodiments, the straps 32 a-f of the implant 30 have tangedportions that directly secure one or more of the straps 32 a-f to atarget tissue region. FIG. 2B shows the implant 30 of FIG. 2A, withtanged portions at the end of each of the straps 32 a-f. In oneexemplary technique, these portions are formed by first forming tangsaround the edges of the implant 30, and then selectively meltingportions of the implant 30 to form the non-tanged portions. Moreparticularly, the implant 30 is first cut from a woven sheet whichexposes fibrous protrusions, or the tangs, around the edges of theimplant 30. The non-tanged portions are then formed by any process thatsmoothes, rounds or removes the protrusions, leaving the tangs aroundthe ends of the straps 32 a-f. In one implementation, the edges of theimplant 30 in the non-tanged portions are heat melted. In anotherexemplary technique, the tangs in implant 30 are formed from anon-tanged woven tape having the approximate dimensions of the implant30 as depicted in FIG. 2B. The smooth sides of the tape are then trimmedto produce the frayed edges or fibrous protrusions of the tanged ends ofstraps 32 a-f. In either technique, the tangs are extremities of fibersof the implant, and the tanged ends of straps 32 a-f form a unitary bodywith the implant 30.

FIG. 3 shows an alternative configuration of a surgical implant 60 foruse in supporting a pelvic region. As shown, the implant 60 has acircular central region 62 and four radially extending extension straps64 a-d. The straps 64 a and 64 c are designed to extend to one obturatormembrane of the patient, and the straps 64 b and 64 d are designed toextend to the contra-lateral obturator membrane of the patient. Thecircular central region 62 is suitable for supporting various anatomicalstructures, including, for example, the base of the bladder. The straps64 a-d can couple with soft tissue anchors for anchoring into respectiveobturator membranes, as will be discussed below. The depicted implant 60is a woven mesh; however, a similarly shaped non-woven implant withtanged straps for anchoring to target tissue regions is discussed below.

As noted in connection with the implant 30 of FIG. 2A, the straps 64a-64 d may also be configured to extend to and secure to other targettissue regions in the patient's retropubic space. In one implementation,straps 64 c-64 d extend to target tissue regions of the patient'sobturator membranes, and straps 64 a-64 b extend to target tissueregions near the patient's tendinous arch of the levator ani muscle.

The implants of FIGS. 2 and 3 described above have extensions/strapsthat can span the obturator-to-obturator length of patients so that theextensions/straps can directly secure to respective obturator membranes,either alone (using, for example, tangs) or in combination withsoft-tissue anchors. FIG. 4 illustrates an alternative straplessembodiment of a surgical implant 70, having lateral length 72 and, invarious embodiments, spanning varying distances between or beyond afirst obturator membrane and the contra-lateral obturator membrane ofthe patient. In certain embodiments the depicted surgical implant 70does not span the full obturator-to-obturator length of many patients,but, as discussed below, couples to soft tissue anchors via longfilaments that attach to the implant. The depicted implant 70 has alateral length 72 of between about 5 centimeters and about 8centimeters. Alternatively, the implant 25 can have a longer laterallength 72, such as greater than about 7 cm, greater than about 9 cm, orgreater than about 10 cm, and thus be sized to span the patient's fullobturator-to-obturator length and directly couple to soft tissue anchorsthat anchor in respective obturator membranes with no interveningfilament.

The depicted implant 70 has an anterior-to-posterior length 74 ofbetween about 2.5 centimeters and about 8 centimeters, which allows thesurgical implant 70 to extend under and provide hammock-like support toposterior regions of the pelvic region, including, for example, the baseof the bladder. In general, the surgical implant 70 can have any desiredanterior-to-posterior lengths 74 to support other anatomical regions ofthe pelvic floor. For example, surgical implant 70 can have ananterior-to-posterior length 74 of between about 0.5 cm and about 2 cmand may be suitable to support one or both of the patient's urethra andbladderneck. Alternatively, surgical implant 70 can have ananterior-to-posterior length 74 of greater than about 3 cm, greater thanabout 5 cm, greater than about 7 cm, or greater than about 10 cm tosupport the patient's urethra, bladderneck, and/or bladder.

The surgical implant 70 is a woven mesh and has interstices betweenconstituent fibers in which tissue in-growth can occur. The surgicalimplant 70 can be made of a wide variety of materials, and can betreated with a variety of therapeutic materials, which are discussed inmore detail in the references cited herein.

The implants can also be configured to have other desired shapes. FIG. 5shows a trapezoidal shaped surgical implant 90 similar to the implant 30of FIG. 2A, but without extension straps. The depicted surgical implant90 has a posterior base length 92 of between about 8 cm and about 11 cm,an anterior base length 94 of between about 5 cm and about 7 cm, and ananterior-to-posterior length 96 of between about 5 cm and about 10 cm.The surgical implant 90 is shaped to have a wider posterior region 90 athan anterior region 90 b because the posterior region 90 a of thesurgical implant 90 supports larger posterior anatomical structures,such as the bladder, whereas the anterior region 90 b of the implant 90supports smaller anterior anatomical structures, such as the urethraand/or bladderneck.

As mentioned above, the surgical implants are generally made of meshmaterials having interstices that promote tissue in-growth. FIG. 6illustrates a surgical implant 120 that, additionally or alternatively,includes a plurality of apertures 122 that can be of varying sizes andthat promote tissue in-growth. This and other exemplary surgicalimplants are further discussed in U.S. Pat. No. 6,197,036, incorporatedherein by reference in its entirety.

As noted, the mesh surgical implants described above may be woven. Theimplants may also be protected with a protective cover or sleeve, asdescribed in U.S. patent application Ser. No. 11/202,554, the contentsof which are incorporated by reference herein in their entirety, to helpprevent the woven implants from unraveling, stretching, and/or otherwisebecoming damaged by stresses applied to the implant during delivery. Thesleeve covers and protects the implant during delivery of the implantthrough tissue, and is removed after delivery. Alternatively, theimplant may be configured in non-woven arrangements that preventunraveling, stretching, and/or damaging during delivery and tensioningof the implant.

FIGS. 7A-14B illustrate various exemplary surgical implants constructedin such a nonwoven configuration. In particular, FIG. 7A shows asurgical implant 140 having a first end 140 a, a second end 140 b, a setof lateral strands 142, and a set of transverse strands 144, while FIG.7B shows a close-up view of the implant 140. The implant 140 includesattachment points 146, wherein the lateral strands 142 intersect withand fuse or otherwise fixedly attach to the transverse strands 144, andopenings 148 defined by the strands 142 and 144 and attachment points146. The implant 140 can be sized to suit a particular application. Forexample, the depicted implant 140 has a lateral width 150 of betweenabout 6 cm and about 11 cm to extend laterally between both of thepatient's obturator foramen, and an anterior-to-posterior width 153 ofbetween about 0.5 cm and about 2 cm to support the urethra and/orbladderneck.

As shown in FIG. 7B, in this illustrative embodiment, the lateralstrands 142 are parallel to the longitudinal axis 158 of the implant,and the transverse strands 144 are substantially perpendicular to thelateral strands 142. The lateral strands 142 and the transverse strands144 can be made of a wide variety of materials, including any of thebiocompatible materials described herein or in the references citedherein. The lateral strands 142 and the transverse strands 144 may bemade of monofilament fibers and/or multifilament fibers. The strands 142and 144 may include different respective materials which provides, forexample, different tension and/or elasticity along a longitudinal axis158 compared to a perpendicular axis 156. In certain embodiments, thelateral strands 142 prevent the implant 140 from stretching laterally.In certain configurations, the lateral strands 142 and the transversestrands 144 have different respective colors. This may help an operatorvisually determine the orientation of the surgical implant 140 as hedelivers and/for tensions the implant 140.

As mentioned above, the implant 140 includes attachment points 146wherein the lateral strands 142 attach to and intersect with thetransverse strands 144. In one embodiment, the attachment is formed by abiocompatible adhesive. Alternatively, the attachment is formed byfusing strands 142 and 144. In other embodiments, the attachment of thestrands 142 and the strands 144 is formed by molding, stamping, and/orlaser cutting.

The implant 140 also includes openings 148, defined by the strands 142and 144, that promote tissue in-growth. The openings 148 may be ofsubstantially similar size and shape. The depicted openings 148 aresubstantially rectangular, but they may have other shapes, and incertain embodiments are parallelogram-shaped. The openings 148 may alsobe of varying sizes and shapes to encourage the formation of varyingtissue in-growth patterns along varying regions of the implant 140according to a medical operator's preference.

The implants described herein are configured to be secured within softtissues within the patient's retropubic space. In one aspect, theimplant 140 includes tanged portions 152 a and 152 b, in which thetransverse strands 144 extend beyond the span of the lateral strands 142along the perpendicular axis 156, and a detanged portion 162 in whichthe length of the transverse strands 144 is substantially equal to thespan of the lateral strands 142 along the perpendicular axis 156. Asshown in FIG. 7B, the tanged portions 152 a and 152 b are formed from aplurality of tangs 160. The tangs 160 interact with surrounding tissueto resist, and optionally prevent, movement of the implant and therebysecure the implant 140 in place until tissue in-growth occurs throughthe openings 148. For example, tanged portions 152 a and 152 b may beplaced directly within obturator foramen, thus securing the implantwithin the obturator foramen without requiring the use of anchors on theends of the implant. Each of the tangs 160 may extend beyond a span ofthe lateral strands 142 by between about 0.5 mm and about 1 mm, bybetween about 1 mm and about 2 mm, by between about 2 mm and about 3 mm,by between about 3 mm and about 4 mm, by between about 4 mm and about 5mm, or by between about 5 mm and about 1 cm. In certain embodiments, thetangs 160 are substantially rigid. For example, they may be made ofmonofilament or multifilament strands with sufficient rigidity to securethe implant 140 to target soft tissue regions without requiring the useof soft tissue anchors.

The implant 140 also includes a detanged portion 162 in which the lengthof the transverse strands 144 is substantially equal to the span of thelateral strands 142 along the perpendicular axis 156. The detangedportion 162 provides a wide support area for an anatomical structure. Incertain implementations, an operator positions the detanged portion 162under sensitive anatomical structures such as the urethra, bladderneckand/or bladder, while the tanged portions 152 a secure the implant 140in place, resulting in lessened irritation to the supported structures.

In one exemplary technique, a manufacturer forms the implant 140 byfirst attaching the strands 142 and 144 using one or more attachmentmethods described above, then forming the tanged portions 152 a-b, andthen forming the detanged portion 162. To form the tanged portions 152a-b, the manufacturer first manufactures the implant 140 with twoadditional lateral strands, depicted by dashed lines 142 a and 142 b,that are configured as the outermost strands in the set of lateralstrands 142. The manufacturer then shortens the transverse strands 144to the outer lateral strands 142 a and 142 b and removes the outer longstrands 142 a and 142 b to expose the tangs 160. The tangs 160 are thusextremities of the transverse strands 144 that make up the implant 140,and the implant 144 and its strands 144 with tangs 160 form a unitarybody. In one exemplary method, the transverse strands 144 are shortenedby heat melting, and in others they are shortened by trimming orcutting. Next, to form the detanged portion 162, a manufacturer heatmelts, cuts, trims, or otherwise shortens the transverse strands 144 tothe outermost strands 142 c and 142 d of the remaining lateral strands142. Because the strands 142 and 144 are individually attached, thestrands 142 and 144 can be cut as desired without causing the implant tounravel.

The tanged and untanged portions of an implant can be sized to achieve adesired anatomical fit and to reduce the level of invasiveness caused byimplantation. FIGS. 8A and 8B show the implant 140 of FIGS. 7A and 7Bwith the tanged portions 152 a and 152 b having been narrowed along theperpendicular axis 156 by cutting or otherwise shortening the tangedportions 152 a-b to reduce the delivery profile of the implant 140. Adelivery profile refers to the maximum cross-sectional area of apassageway through the patient's anatomy that is required for deliveryof the implant 140. The delivery profile may be effected by one or moreof a number of factors, including the diameter of the delivery needles,shafts, and/or dilators, implant width, and protective sleeve width.

Smaller delivery profiles can be beneficial because they may result inless invasive implant delivery procedures. An implant having the smallerprofile illustrated in FIGS. 8A-B may be delivered using a deliverydevice with smaller dimensions, such as a smaller shaft or needle, whichmay reduce trauma to the patient and damage less tissue. However,implants with larger profiles, such as implant 140 as shown in FIGS. 7Aand 7B, may more securely anchor within the patient's anatomy andprovide an operator with more control during delivery, and the operatorcan select an implant having a delivery profile that is suitable for thepatient. The anterior-to-posterior width of the detanged portion 162 hasnot been narrowed and thus provides a wide support area for ananatomical structure.

FIG. 9 shows an alternative implant embodiment with a still furtherreduced delivery profile. As shown each of the tanged portions 152 a and152 b includes a single lateral strand 170 having end portions 170 a and170 b. The tangs are formed from transverse strands 172 attached to thelateral strand 170 in a perpendicular orientation. In one exemplaryapplication, an operator uses a delivery device with a fork-shaped tipto deliver, position, and/or adjust the placement of the implant 140.The operator interfits the prongs of the fork-shaped tip around the longstrand near end portion 170 a, for example, at regions 174 a and 174 b.The fork-shaped tip abuts one of the transverse strands 172 a and theoperator pulls or drags the implant 140 in a desired direction. In thisembodiment, if one or both of the tanged portions 152 a and 152 b twistabout the longitudinal axis 158 during delivery or placement, tissuein-growth in surrounding tissue regions may be substantially unaffected.Thus, the operator does not need to prevent twisting of the implant 140during delivery.

The implants may also be shaped as needed to achieve desired elasticityand elongation properties. FIG. 10 shows an exemplary implant 180 havinglateral strands 182 and transverse strands 184, tanged portions 186 aand 186 b and a non-tanged portion 188. The implant 180 is similar toimplant 140 of FIG. 7A, except that the transverse strands 184 areoriented at an opposing and non-perpendicular angle 190 with respect tothe lateral strands 182, so that the implant 180 includes openings 192that are substantially diamond shaped. Orienting the transverse strands184 in this manner allows the implant 180 to stretch in the transversedirection 194 without damaging the implant 60. More particularly, duringimplantation or use, when transverse stress or tension is applied alongthe anterior-to-posterior width 194, the transverse strands 184 shiftand orient themselves perpendicularly to the lateral strands 182. Thisincreases the anterior-to-posterior width 194 which allows the implant180 to absorb the transverse stress without damaging the implant 180.

FIG. 1A illustrates an exemplary extrusion technique for constructing asurgical implant 210 similar to surgical implant 180 of FIG. 10, andFIG. 11B illustrates a block diagram of the technique. In the technique,a manufacturer first extrudes and fuses two sets of strands, and thencuts the resulting structure to size and shape the implant 210.

More particularly, a manufacturer first extrudes the first set ofstrands 212 (step 230) at a first angle with respect to the longitudinalaxis 214. To do so, in one implementation, the manufacturer pushesand/or draws a feedstock of the implant material through an extrusiondie that includes respective apertures for each of the first set ofstrands 212. The apertures are arranged in a circular configuration andoriented at the first angle with respect to the longitudinal axis 214 sothat the first set of strands form a tube of parallel strands.

Next, the manufacturer extrudes a second set of strands 216 (step 232)at a second angle with respect to the longitudinal axis 214. To do so,in one implementation, the manufacturer pushes and/or draws a feedstockof the implant material through a second extrusion die that includesrespective apertures for each of the second set of strands 216. Theseapertures are also arranged in a circular configuration and oriented atthe second angle with respect to the longitudinal axis 214, so that thesecond set of strands forms a tube of parallel strands and intersectswith the first set of strands 212 at a plurality of attachment points218. The manufacturer then fuses the first set of strands 212 to thesecond set of strands 216 (step 234) at the attachment points 218, andthus forms a substantially continuous tube.

Next, the manufacturer cuts the implant 210 to an appropriate lengthalong longitudinal axis 214 (step 235) and cuts the implant 210longitudinally along one lateral wall of the tube (step 236) to open thetube into a flat shape. In certain embodiments, the cuts in the lateralwall allow the first set of strands 212 or the second set of strands 216to be oriented parallel to the longitudinal axis 214 of the implant.This results in a configuration similar to that shown in FIG. 10, wherethe long strands 182 are parallel to the longitudinal axis 181 of theimplant 180. As mentioned, such an orientation helps reduce stretchingin the lateral direction during delivery of the implant 210. In otherembodiments, the number of strands is increased or decreased to alterthe diameter of the tubular shape in order to vary the size of the finalconfiguration of the implant. Finally, the operator optionally cuts theimplant to a desired size and shape (step 238), and optionally formstangs as described above (step 240). The operator may also optionallycouple the implant to one or more soft tissue anchors, as describedherein.

The implants described above in relation to FIGS. 7A-11B include twosets of strands, which in the illustrated embodiments include a firstset of long strands and a second set of short strands. In alternativeembodiments, additional sets of strands may be included to provideadditional strength, tension, or elasticity properties. FIG. 12illustrates a portion of any exemplary surgical implant 250 having threesets of strands—a first transverse set 252, a second lateral set 254,and a third cross-oriented set 256. The strands within each set aresubstantially parallel and in certain embodiments lie in differentrespective layers. Each layer is oriented at a different angle withrespect to the longitudinal axis 257 and is fixedly attached to at leastone other layer. As shown, the strands of each of sets 252, 254, and 256attach to strands in one or both of the other two sets to form aplurality of intersection points 258 having strands of two or more ofthe sets fused, melted, or otherwise attached using methods discussedabove.

The implants described with respect to FIGS. 7A-12 are sized and shapedto support anatomical structures such as the urethra and/or thebladderneck of the patient. Similarly constructed implants can be sizedand shaped to support other anatomical structures and extend to otherpelvic regions. FIG. 13 illustrates a surgical implant 280 constructedsimilar to the implant 140 of FIG. 7A, but sized and shaped similar tothe implant 70 of FIG. 4. In particular, the implant 280 has a longeranterior-to-posterior length 282 than does implant 140, which allows theimplant 280 to support posterior regions of the pelvic region, such astissue regions posterior to the patient's bladderneck and under the baseof the patient's bladder. Additionally, the depicted surgical implant280 has a smaller lateral length 284 than the lateral length of thesurgical implant 140 of FIG. 7A, such that the implant 280 does not spanthe full obturator-to-obturator length of the patient. Instead, asdiscussed below, the surgical implant 280 couples to soft tissue anchorsthat are spaced from the implant 280 by long filaments 286 which spanthe remainder of the obturator-to-obturator length when the soft tissueanchors anchor to respective obturator membranes. Although not shown,one or more of the edges of surgical implant 280 may include tangs asdescribed above. In any of the exemplary embodiments, tangs areoptional, particularly when soft tissue anchors are used to anchor thesurgical implants to respective obturator membranes.

FIGS. 14A-B illustrate exemplary alternative surgical implants 300 and310 that are sized and shaped to extend to posterior regions of thepelvic floor and to support anatomical structures such as the bladder.The implant 310 depicted in FIG. 14B is sized and shaped similar to theimplant 60 of FIG. 3, but is manufactured according to the non-wovenconfiguration described above in connection with FIGS. 7A-12. Theillustrative implant 300 in FIG. 14A is circular and has a center 302, afirst set of strands 304 formed as concentric circles of increasingradii about center 302, and a second set of strands 306 that extendradially from the center 302. The implant 300 includes tangs 308, but inalternative embodiments, portions of the implant may be detanged asdescribed above.

In one exemplary manufacturing technique, a manufacturer selectivelyremoves portions of the surgical implant 300 depicted in FIG. 14A toconstruct the surgical implant 310 of FIG. 14B. In particular, portions303 a-303 d are removed by cutting, trimming, melting, laser cutting, orusing other like methods. The removal of the portions 303 a-303 dshortens some of the radial strands 306 a-306 d and, optionally leavesthem detanged. Similarly, the removal of portions 303 a-303 d leaves theconcentric circular strands 304 in segments 304 a-304 d, which aredepicted as being tanged. The resulting implant 310 thus includes acentral untanged portion 314 with multiple radially extending tangedextensions 316 a-d. The depicted central untanged portion 314 iscircular for supporting various anatomical structures including, forexample, the base of the bladder. The radially extending tanged portions316 a-d can extend to and anchor to respective obturator membraneseither alone or in combination with soft tissue anchors, as will bediscussed below.

The implants discussed above generally lie flat when not in use.However, in one aspect, the implants described herein may be pre-shapedto curve and fit around desired anatomical locations. For example, FIG.15A shows an implant 320 that is sized and pre-shaped to fit under andsupport a urethra and/or a bladderneck. The implant 320 includes anindented portion 322 that is designed to interfit under the bladderneckand/or the urethra, to impede the implant 320 from exerting excessivestress on the bladderneck and/or urethra.

In one exemplary technique, the indented portion 322 is formed bygathering and compressing the portion 322 of the implant 320 using aclip 324 shown in FIG. 15B that is aligned along theanterior-to-posterior direction 328 of the implant 320. In particular,the operator squeezes together levers 326 a and 326 b and opens the clip324, then places the portion 322 of the implant 320 in the clip 324,releases the levers 326 a and 326 b to close the clip, and then foldsthe ends 320 a and 320 b over respective levers 326 a and 326 b. Afterwaiting for a sufficient period of time for the implant 320 to maintainits folded configuration upon removal of the clip 324, the operatoropens the clip and releases the implant 320, which is then shaped asillustrated in FIG. 15A.

Larger pelvic floor implants described above, including those sized andshaped to extend to and support a patient's bladder, can be similarlypre-shaped using larger clips 324, or by using multiple clips 324 ormultiple uses of a single clip 324 at various locations along theimplant 320. The depicted indented portion 322 extends in theanterior-to-posterior direction 328, but in other implementations theindented portion 322 may also extend in a lateral direction 330. Thiscan be done by, after forming the indented portion 322 as describedabove, gathering and compressing a portion of the implant 320 with theclip 324 aligned along the lateral direction 330 of the implant 320.

The implants described above can be constructed from a variety ofmaterials. There are many possible mesh materials, and the implant may,in the alternative or in combination, be made of other types ofmaterials. Exemplary mesh materials include, for example, syntheticmaterials, natural materials (e.g., biological) or a combinationthereof. The mesh may be fabricated from any of a number ofbiocompatible materials, such as nylon, silicone, polyethylene,polyester, polyethylene, polyimide, polyurethane, polypropylene,fluoropolymers, copolymers thereof, combinations thereof, or othersuitable synthetic material(s). The material may be, for example, abiodegradable synthetic material. The term “biodegradable,” as usedherein, refers to the property of a material that dissolves in the body.Such materials may also be absorbed into the body, i.e., bioabsorbable.

Suitable bioabsorbable synthetic materials include, without limitation,polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid(PLLA), human dermis and decellularized animal tissue. Human tissues maybe derived, for example, from human cadaveric or engineered humantissue. Animal tissues may be derived, for example, from porcine, ovine,bovine, and equine tissue sources. The material may be anomnidirectional material, a material that has equivalent tensilestrength from any direction, such as pericardium or dermis.Alternatively, the material may be an oriented material, a material thathas a single direction where the tensile strength of the material is thehighest. Oriented materials may include rectus fascia and/or facia lata,as well as oriented synthetic materials.

Exemplary biodegradable polymers, which may be used to form the tubularmesh 100, in addition to those listed above, include, withoutlimitation, polylactic acid, polyglycolic acid and copolymers andmixtures thereof, such as poly(L-lactide) (PLLA), poly(D,L-lactide)(PLA), polyglycolic acid [polyglycolide (PGA)],poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(Llactide-co-glycolide)(PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA),poly(glycolideco-trimethylene carbonate) (PGA/PTMC),poly(D,L-lactide-co-caprolactone) (PLA/PCL), andpoly(glycolide-co-caprolactone) (PGA/PCL); polyethylene oxide (PEO);polydioxanone (PDS); polypropylene fumarate; polydepsipeptides,poly(ethyl glutamate-co-glutamic acid), poly(tertbutyloxy-carbonylmethylglutamate); polycaprolactone (PCL), poly(hydroxy butyrate),polycaprolactone co-butylacrylate, polyhydroxybutyrate (PHBT) andcopolymers of polyhydroxybutyrate; polyphosphazenes, polyphosphateester); maleic anhydride copolymers, polyiminocarbonates, poly[(97.5%dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)],cyanoacrylate, hydroxypropylmethylcellulose; polysaccharides, such ashyaluronic acid, chitosan, alginates and regenerate cellulose;poly(amino acid) and proteins, such as gelatin and collagen; andmixtures and copolymers thereof.

The systems, devices and methods described herein may be combined withother techniques for treating UI and/or pelvic floor disorders. Forexample, while the implants described herein are suitable for use in thesingle vaginal incision procedure, such implants may also be used inmulti-incision procedures such as those described in US PatentPublications 2005/0245787, 2005/0250977, 2005/0075660, U.S. Pat. No.6,911,003, and other systems. In certain implementations, the meshesused to support the urethra and/or pelvic organs may, either as a wholeor on a fiber-by-fiber basis, include an agent for release into thepatient's tissues. One illustrative agent is a tissue growth factor thatpromotes, when applied to the patient's tissues in a pharmaceuticallyacceptable amount, well-organized collagenous tissue growth, such asscar tissue growth, preferably, in large quantities. According to onefeature, the agent may or may not block or delay the dissolvability ofthe biodegradable materials. This may be controlled by selectingdiffering methods for loading the agent onto the implant. The tissuegrowth factor may include natural and/or recombinant proteins forstimulating a tissue response so that collagenous tissue such as scartissue growth is enhanced. Exemplary growth factors that may be usedinclude, but are not limited to, platelet-derived growth factor (PDGF),fibroblast growth factor (FGF), transforming growth factor-beta(TGF-beta), vascular endothelium growth factor (VEGF), Activin/TGF andsex steroid, bone marrow growth factor, growth hormone, Insulin-likegrowth factor 1, and combinations thereof. The agent may also include ahormone, including but not limited to estrogen, steroid hormones, andother hormones to promote growth of appropriate collagenous tissue suchas scar tissue. The agent may also include stem cells or other suitablecells derived from the host patient. These cells may be fibroblast,myoblast, or other progenitor cells to mature into appropriate tissues.Besides applying active pharmaceutical agents, passive agents may beapplied to promote tissue in-growth. For example, titanium sputtering orchrome sputtering can be used.

In various illustrative embodiments, the agent may include one or moretherapeutic agents. The therapeutic agents may be, for example,anti-inflammatory agents, including steroidal and non-steroidalanti-inflammatory agents, analgesic agents, including narcotic andnon-narcotic analgesics, local anesthetic agents, antispasmodic agents,growth factors, gene-based therapeutic agents, and combinations thereof.

Exemplary steroidal anti-inflammatory therapeutic agents(glucocorticoids) include, but are not limited to,21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumehtasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol priopionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methyolprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylaminoacetate, prednisone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortal, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, and pharmaceutically acceptable salts thereof.

Exemplary non-steroidal anti-inflammatory therapeutic agents include,but are not limited to, aminoarylcarboxylic acid derivatives such asenfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamicacid, mefanamic acid, niflumic acid, talniflumate, terofenamate andtolfenamic acid; arylacetic acid derivatives such as acemetacin,alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium,etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac,glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac,metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide,tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon,butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac,ketorolac and tinoridine; arylpropionic acid derivatives such asalminoprofen, benoxaprofen, bucloxic acid; carprofen, fenoprofen,flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen,ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen,pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid;pyrazoles such as difenamizole and epirizole; pyrazolones such asapazone, benzpiperylon, feprazone, mofebutazone, morazone,oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone,ramifenazone, suxibuzone and thiazolinobutazone; salicylic acidderivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin,calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisicacid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate,mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine,parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide,salicylamine o-acetic acid, salicylsulfuric acid, salsalate andsulfasalazine; thiazinecarboxamides such as droxicam, isoxicam,piroxicam and tenoxicam; others such as s-acetamidocaproic acid,s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine,bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone,guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline,perisoxal, pifoxime, proquazone, proxazole and tenidap; andpharmaceutically acceptable salts thereof.

Exemplary narcotic analgesic therapeutic agents include, but are notlimited to, alfentanil, allylprodine, alphaprodine, anileridine,benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene,codeine, codeine methyl bromide, codeine phosphate, codeine sulfate,desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine,dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol,dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone,eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine,etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine,isomethadone, ketobemidone, levorphanol, lofentanil, meperidine,meptazinol, metazocine, methadone hydrochloride, metopon, morphine,myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol,normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone,papavereturn, pentazocine, phenadoxone, phenazocine, pheoperidine,piminodine, piritramide, proheptazine, promedol, properidine, propiram,propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceuticallyacceptable salts thereof.

Exemplary non-narcotic analgesic agents that may be combined with theimplants of the invention include, but are not limited to, aceclofenac,acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid,alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate),aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine,ammonium salicylate, amtolmetin guacil, antipyrine, antipyrinesalicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen,benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide,5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin,calcium acetylsalicylate, carbamazepine, carbiphene, carsalam,chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen,ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol,difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate,dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole,etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone,flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazolesalicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin,ketoprofen, ketorolac, p-lactophenetide, lefetamine, loxoprofen, lysineacetylsalicylate, magnesium acetylsalicylate, methotrimeprazine,metofoline, miroprofen, morazone, morpholine salicylate, naproxen,nefopam, nifenazone, 5′nitro-2′ propoxyacetanilide, parsalmide,perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll,phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol,pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone,proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate,salacetamide, salicin, salicylamide, salicylamide o-acetic acid,salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate,sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate,tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol,xenbucin, zomepirac, and pharmaceutically acceptable salts thereof.

Exemplary local anesthetic therapeutic agents include, but are notlimited to, ambucaine, amolanone, amylocalne hydrochloride, benoxinate,benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben,butanilicaine, butethamine, butoxycaine, carticaine, chloroprocainehydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucainehydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride,dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin,fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine,isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine,mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine,naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacainehydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine,prilocalne, procaine, propanocaine, proparacaine, propipocaine,propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine,salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine,zolamine, and pharmaceutically acceptable salts thereof.

Exemplary antispasmodic therapeutic agents include, but are not limitedto, alibendol, ambucetamide, aminopromazine, apoatropine, bevoniummethyl sulfate, bietamiverine, butaverine, butropium bromide,n-butylscopolammonium bromide, caroverine, cimetropium bromide,cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride,cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate,diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine,fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentoniumbromide, flavoxate, flopropione, gluconic acid, guaiactamine,hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine,nafiverine, octamylamine, octaverine, oxybutynin chloride,pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaveriumbromide, piperilate, pipoxolan hydrochloride, pramiverin, prifiniumbromide, properidine, propivane, propyromazine, prozapine, racefemine,rociverine, spasmolytol, stilonium iodide, sultroponium, tiemoniumiodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,trifolium, trimebutine, n,n-ltrimethyl-3,3-diphenyl-propylamine,tropenzile, trospium chloride, xenytropium bromide, and pharmaceuticallyacceptable salts thereof.

Having described various surgical implants sized, shaped, andconstructed for UI and/or pelvic floor repair, and exemplary methods ofconstruction, we next describe soft tissue anchors that may optionallybe used to secure the surgical implants to a desired anatomicallocation, such as obturator membranes, and methods for coupling the softtissue anchors to the surgical implants. In use, as mentioned above, thesurgical implants are inserted and positioned in a desired locationwithin the pelvic region of the patient through a single incision in thepatient's vaginal wall and then anchored to soft tissue regions such asobturator membranes.

In general, soft tissue anchors are biocompatible structures that arefixed to or interoperationally connected to an implant and are adjustedto anchor to patient's pelvic tissue. In certain embodiments, the softtissue anchors are sling housings directly formed and/or fitted as endterminations around ends of the implant, and in others the soft tissueanchors and the implant are separate elements that can be assembled toform an implant assembly. Moreover, the anchors may be directly coupledto a surgical implant, or indirectly coupled to the implant via, forexample, filaments or rings that space the anchors away from thesurgical implant. The soft tissue anchors may adjustably couple to thesurgical implant to allow an operator to tension the implant afteranchoring in the patient. The soft tissue anchors can include barbs thatanchor to the obturator membrane, or can be smooth, in which case theoperator positions the anchor to act as a mechanical stop and preventdisengagement from the obturator membrane. The soft tissue anchors mayalso be bioabsorbable and absorb into surrounding tissue after beingimplanted into the pelvic region of the patient.

FIGS. 16A-16C depict an implant assembly 400 having soft tissue anchorsthat are configured as housings around ends of a surgical implant 401 toanchor the implant and couple the implant with delivery devices.

More particularly as shown in FIG. 16A, the implant assembly 400includes housings 402 and 404 which are end terminations formed and/orfitted around the end of the mesh implant 401 that taper away from theend of the implant 401 about which they are formed and/or fitted. Theend termination 402 includes a ring or aperture 416 and first and secondlegs 412 and 414 that extend radially from the aperture 416. Theaperture 416 is sized and shaped to engage with a delivery device, suchas, for example, the distal end of a shaft, needle or dilator of any ofthe delivery devices described below. The assembly 400 also includes anend termination 404 that is similar to end termination 402. Inparticular, end termination 404 includes legs 406 and 408 extendingradially from aperture 410. In operation, an operator places theaperture 416 (or 410) over the tip of a delivery device shaft and slidesthe aperture 416 down the tip until the aperture 416 abuts against astep, shoulder, or other stopping mechanism, as will be discussed inmore detail below. The apertures 410 and 416 include inner surfaces 410a and 416 a that, in certain embodiments, are tapered to inter-fit withthe tip of a delivery device.

The depicted apertures 410 and 416 are coplanar with the implant 401. Asa result, the implant assembly 400 has a low delivery profile. Asmentioned above, a delivery profile refers to the maximumcross-sectional area of a passageway through the patient's anatomy thatis required for placement of the implant, and smaller delivery profilesare beneficial at least in part because they may reduce tissue damageduring implant delivery. Moreover, apertures 410 and 416 may be anyshape, including square, triangular, oval, or other preferred shapes.The apertures 410 and 416 may also be any size, and in particular may beconfigured to couple with shafts or needles of varying dimensions.

The legs on the end termination 402 and 404 are sized and shaped toengage with and attach to the implant 401 to help anchor the implant 401inside the patient. More particularly, referring to the end termination402, the legs 412 and 414 extend radially from the respective aperture416 and adjoin at angle 418. In certain embodiments, the end termination402 is flexible such that the angle 418 can be increased or decreasedupon application of appropriate mechanical pressure. By way of example,if the implant 401 passes through tissue in a forward direction 420, thelegs 412 and 414 interact with the tissue to reduce the angle 418. Ifthe implant 401 passes through tissue in a retrograde direction 422, thelegs 412 and 414 are pushed outward by the tissue to increase the angle418. The varying angle 418 thus facilitates movement of the implant 401in the forward direction 420, and impedes movement of the mesh strap 401in the retrograde direction 422. In certain embodiments, the angle 418can vary from between about 0 degrees to about 90 degrees, and in otherembodiments can vary to more than about 90 degrees. The angle 418 formedbetween the legs 412 and 414 can vary, as can the flexibility of the endtermination 402. These properties are generally chosen to suit theparticular delivery path and location for anchoring the implant, as wellas the condition being treated.

Additionally, the V-shaped configuration of legs 412 and 414 acts toengage with patient tissue to resist removal once the implant assembly400 is implanted. The depicted legs 412 and 414 extend beyond the width401 a of implant 401 to provide additional engagement with tissue, butin other illustrative embodiments may be of any length, and may notextend beyond the width 401 a of the implant 401. The features describedherein with regard to end termination 402 may also apply to endtermination 404.

The end termination may be connected to the implant by gluing, stapling,soldering, molding, or other methods. FIG. 16B shows an embodiment inwhich the end terminations 402 and 404 are molded to the implant 401. Inan exemplary manufacturing technique, a manufacturer inserts an end 401b of the implant 401 into a mold (not shown) that has passages orcavities shaped like end termination 402 (i.e., including cavitiesshaped like ring 416 and legs 412 and 414). Next, the manufacturerinjects a curable material, such as a curable biocompatible plastic,into the mold. After the curable material cures, the manufacturerdecouples the mold and the implant 401, and then trims, melts, orotherwise removes excess molding material 419. The process is repeatedfor the other side 401 c of the implant 401 to form end termination 404,the manufacturer then trims, melts, or otherwise removes excess meshcorners 401 d, 401 e, 401 f, and 401 g of the implant 401.

FIG. 17 illustrates an end termination similar to the end terminations402 and 404, but which does not need to be molded directly on animplant. This end termination includes a top piece 420 and a bottompiece 422. The bottom piece 422 includes two legs 424 and 426 that forma V-shape and an aperture 428 located between the V-shaped legs 424 and426. The top piece 420 is shaped to align with the bottom piece 422, andin particular includes two legs 429 and 430 that form a V-shape and anaperture 432 located between the V-shaped legs 429 and 430. The toppiece 420 further includes a plurality of apertures or cavities (notshown) that align with a plurality of projections 434 that are designedto interfit within the apertures or cavities. In operation, amanufacturer secures an implant 401 between the top piece 420 and thebottom piece 422 by disposing an end of the implant 401 b between thetop piece 420 and the bottom piece 422. The projections 434 pass throughinterstitial spaces between filaments of the implant 401 and snap-fitinto the corresponding apertures or cavities (not shown) in the toppiece 420. In addition to or as an alternative to using the projections434 and the corresponding apertures or cavities, a manufacturer maysecure the top piece 420 and the bottom piece 422 by gluing,heat-bonding, molding, or otherwise attaching the top piece 420 and thebottom piece 422 to each other and/or to the implant 401.

In alternative configurations, the end terminations are provided withoutradially extending legs. FIG. 18 shows an implant assembly 440 includingan implant 442 and two end terminations 444 and 446 formed as respectiveapertures with no legs. A manufacturer affixes end terminations 444 and446 to the implant 442 using any of the methods described above. In thedepicted implant assembly 440, the corners of the implant 442 aretrimmed at locations 442 a, 442 b, 442 c, and 442 d.

FIGS. 19A and 19B show an alternative end termination 450 that isflexible and made of a softer material, such as a soft durometerbiocompatible material, than the previously described end terminations.The end termination 450 can couple to a surgical implant using any ofthe methods described herein with respect to other end terminationembodiments. As shown in FIG. 19A, the end termination 450 includes anaperture 452, a first leg 454, and a second leg 456. The first leg 454and the second leg 456 form a V-shape, and the aperture 452 lies in aplane that is perpendicular to the plane extending through the first andsecond legs 454 and 456. This perpendicular orientation results in thedistal end of the shaft 458 aligning with the implant (not shown), andmay be preferred by an operator for delivery of an implant. Since theend termination 450 is made of a relatively soft material, the ring 452is in a collapsed state when the end termination 450 is at rest, asshown in FIG. 19A. In use, an operator couples the end termination 450to a delivery device (not shown) by sliding the aperture 452 around ashaft 458 of the delivery device as depicted in FIG. 19B. The aperture452 expands as the shaft 458 is pushed within the aperture 452,expanding the aperture 452 into a substantially circular configuration.The operator delivers the end termination 450 to a target tissue region,and retracts the shaft 458 to decouple the shaft 458 from the endtermination 450. After the operator retracts the shaft 458, the aperture452 returns to the collapsed state illustrated in FIG. 19A. Thecollapsed state provides a lower profile for the end termination 450after the end termination 450 is implanted. As mentioned above, lowprofile implant assemblies may lessen damage to surrounding tissues.

FIG. 20 shows another embodiment of an implant assembly 460 havingalternative low profile end terminations 463 and 464 that liesubstantially in the plane of the implant 466. End termination 464includes a tab shaped region 468, an aperture 470 disposed within thetab shaped region 468, and legs 472 and 474 extending radially from theaperture 470. The depicted aperture 470 is small (i.e., in certainembodiments having a diameter of less than about 2 mm), and is sized tocouple with a narrow needle of a delivery device. In other embodiments,the aperture 470 is sized to allow an operator to thread a filamenttherethrough. The filament may couple to a separate soft tissue anchoras described in connection with other embodiments herein. Similar to thelegs described in connection with FIG. 16A above, the legs 472 and 474anchor the implant 466 to soft tissue. In an exemplary manufacturingtechnique, a manufacturer dips the implant 466 in a curable plastic toform the end termination 468. The manufacturer then trims the plastic tocreate the tab shape 468 and the optional legs 472 and 474, and punchesa hole through the plastic to create the aperture 470. However, inalternative embodiments, the manufacturer may pre-form the endtermination 464 and subsequently snap-fit, glue, stitch, or otherwiseattach it to the implant 466.

Alternative end termination 463 also includes a tab-shaped region 473but does not include an aperture. Instead, end termination 463 includesa conical projection 475. The conical projection 475 is designed tointerfit about the distal end of a delivery device shaft, such as theneedle 477. In operation, an operator interfits the needle 477 with theprojection 475 and drags the implant 466 towards a target tissue region.The projection 475 need not be conical, and in certain embodiments it ispyramidal.

As mentioned above, in certain embodiments, the soft-tissue anchors andthe implant are separate elements that are assembled as an implantassembly. FIGS. 2A-D illustrate exemplary barbed soft tissue anchorsthat can be used for this purpose. In FIG. 2A, the anchor 500 includes athrough-aperture 502, a body 504 and two rows of radial projections, orbarbs 506. The through-aperture 502 couples to a shaft of a deliverydevice by fitting around the shaft, as will be discussed below. Thedepicted through-aperture 502 extends axially entirely through the body504 of the anchor 500. In other embodiments, the body 504 includes apassage extending axially from the proximal end 500 b of the anchor 500only part way to the distal end 500 a of the anchor 500.

The barbs 506 are relatively short (e.g., less than about 2 millimetersin length) and relatively wide (e.g., between about 1 millimeter andabout 2 millimeters in width/diameter). Additionally, they haverelatively flat terminal ends 508. The barbs 506 are also flexible. Whenan operator inserts the anchor 500 into an obturator membrane, the barbs506 flex and compress against the body 504 of the anchor 500 to allowpassage at least partially through the obturator membrane. Afterinsertion within the obturator membrane, the barbs 506 expand radiallyfrom the body 504 and thereby resist retrograde motion back through theobturator membrane, thereby impeding the anchor 500 from disengagingfrom the obturator membrane.

FIG. 21B shows an alternative embodiment of an anchor 510, having athrough-aperture 512, a body 514 and two rows of radial projections 516.The projections 516 are relatively long (e.g., greater than or equal toabout 2 millimeters in length) and relatively wide (e.g., between about1 millimeter and about 2 millimeters in width/diameter), as comparedwith anchor 500 of FIG. 2A.

FIG. 21C shows another embodiment of an anchor 520 having a body 522, anaxially extending through-aperture 524 and radial projections 526. Theanchor 520 is similar to anchors 500 and 510 of FIGS. 2A and 21B,respectively, except that the radial projections 526 have pointed ratherthan flat terminal ends, in contrast to the projections 506 and 516. Thepointed projections 526 impede retrograde forces that may be applied tothe anchor 520, since the projections 526 more firmly incise into andengage with the tissue of the obturator membrane and thereby preventdisengagement of the anchor 520 from the obturator membrane. Inparticular, the projections have an initial width at a base 530comparable to the width of the projections 506 and 516, and have alength similar to that of the projections 506.

FIG. 21D shows another illustrative anchor 540, including a relativelylong (e.g., between about 2.5 centimeters and about 3.5 centimeters)body 542 and five rows of relatively long (e.g., greater than about 5millimeters) radial projections 544. As in the case of the abovedescribed examples, the anchor 540 includes a radially extendingthrough-passage 546.

FIG. 21E shows the barbed anchor 540 coupled to a portion of a surgicalimplant 550 and anchored to an obturator membrane 552. In operation, anoperator drives the anchor 540 partially (as illustrated) or entirelythrough the obturator membrane 552 using a delivery device and/or methodthat will be discussed below. The barbs 544 on the anchor 540 engagewith the obturator membrane 552 and inhibit the anchor 540 fromretracting out of the membrane 552 after insertion. An operator thenoptionally drives the anchor 540 further into the obturator membrane 552to tension the associated surgical implant 550. The long body 542 isbeneficial in part because the operator can drive the anchor 540 variousdistances through the obturator membrane 552, corresponding to varioustensions of implant 550. When the operator drives the anchor 540entirely through the obturator membrane 552, the surgical implant 550 isdriven through the obturator membrane 552. The implant 550 may havetangs to engage with and anchor to the obturator membrane 552. Theoperator can then extend or retract a portion of the implant 550 throughthe obturator membrane 552 to tension the implant 550. In certainembodiments, the implant 550 is not coupled to soft tissue anchor 540and anchors itself to the obturator membrane 552.

FIG. 22A illustrates a soft tissue anchor 560 without barbs. Inparticular, the soft tissue anchor 560 has a smooth outer surface 562.Like the anchors depicted in FIGS. 21A-E, the anchor 560 includes athrough-aperture 564 that fits around the shaft of a delivery device, aswill be discussed below. The depicted through-aperture 564 extendsaxially entirely through the anchor 560. In other embodiments, theanchor 560 includes a passage extending axially from the proximal end560 b of the anchor 500 only part way to the distal end 560 a of theanchor 560.

FIGS. 22B-22C illustrate an exemplary technique for using the anchor 560to anchor a surgical implant 566 to an obturator membrane 568. Inparticular, an operator foul's an aperture 570 within the obturatormembrane 568 using, for example, a needle or dilator. Next, the operatorcouples the anchor 560 to an implant 566 using methods discussed below.The operator then drives the anchor 560 through the aperture 570. Whenretrograde tension is applied to the implant 566, the anchor 560 pivotsto a horizontal orientation, depicted in FIG. 22C, and aligns with theobturator membrane 568, and this horizontal orientation prevents theanchor 560 from disengaging from the obturator membrane 568.

FIG. 23 illustrates an alternative soft tissue anchor 570 shaped like anarrowhead. More particularly, the anchor 570 includes a point 572 at adistal end, a cylindrical shaft 574 at a proximal end, and wings 576 aand 576 b at a distal end of the cylindrical shaft 574. The anchor 570further includes a slot 578 disposed longitudinally along thecylindrical shaft 574 and a cross bar 580 bridging the slot 578. In oneexemplary technique, an operator couples the anchor 570 to a filament byinterfitting the filament through slot 578 and threading the filamentaround the cross bar 580.

As mentioned above, the soft tissue anchors couple to surgical implantsin a variety of ways. In certain embodiments, such as with pelvic floorrepair implants that have long lateral widths or laterally extendinglegs or extension regions, they directly couple to the surgical implant.In others, they are spaced away from the surgical implants. In any case,the anchors may be fixedly coupled, or adjustably coupled so that anoperator can tension the implant.

FIG. 24 illustrates a surgical implant 580, similar to the surgicalimplant 30 depicted in FIG. 2A, with soft tissue anchors 582-587 coupleddirectly to respective ones of the straps 590-595. In certainembodiments, the anchors are fixedly coupled to the respective straps,as depicted with respect to soft tissue anchors 582-584. The ends 582 a,583 a, and 584 a of the anchors 582-584 are affixed to respective ends590 a, 591 a, and 592 a of the straps 590-592 by gluing, heat bonding,tying, or other permanent affixation methods.

In other embodiments, the anchors are adjustably coupled to respectivestraps, as depicted with respect to soft tissue anchors 585-587. Asshown, the mesh straps 593-595 are threaded through buckles or aperturesof the anchors 585-587, which exposes free ends 593 a, 594 a, and 595 aof the mesh straps that have threaded entirely through the anchors585-587. The operator can pull free end 595 a to thread more of meshstrap 595 through anchor 587 and increase the length of the exposed freeend 595 a. As a result, the tension applied by strap 595 to the surgicalimplant 580 will increase. The operator can similarly tension theimplant 580 by adjusting the other mesh straps.

As mentioned above, certain exemplary surgical implants may be used thatdo not extend the full obturator-to-obturator length of the patient. Insuch instances, soft tissue anchors can indirectly couple to thesurgical implant via, for example, filaments or rings which space theanchors away from the surgical implant to extend the anchoring points.FIG. 25A illustrates a surgical implant 600 coupled with soft tissueanchors 602 and 604 via elastic rings 606 and 608. The rings 606 and 608couple their respective anchors to the implant by a set ofthrough-apertures. More particularly, the ring 606 couples with anchor602 by threading through the apertures 614 and 616 in soft tissue anchor602, and couples with surgical implant 600 by threading through theapertures 610 and 612 in surgical implant 600. Similarly, the ring 608couples to soft tissue anchor 604 by threading through the apertures 622and 624 in soft tissue anchor 604, and couples to the surgical implant600 by threading through the apertures 618 and 620 in the surgicalimplant 600. As mentioned above, woven surgical implants may stretch anddamage due to stresses during delivery of the implant. The elastic rings606 and 608 stretch to absorb lateral stresses, thereby preventingdamage to the implant 600 during delivery.

Additionally, the elastic rings 606 and 608 adjust to short term and/orlong term changes in the patient's changing anatomy to prevent damage tothe surgical implant 600. For example, when the patient sneezes, coughs,or jumps, muscles in the pelvic region can contract and anatomicalstructures may shift. Anatomical structures may also shift over longperiods of time because of the patient's changing anatomy due to, forexample, weight gain or weight loss. In such cases, the elastic rings606 and 608 stretch to absorb the stresses caused by these short-termand long-term changes, thereby preventing the changes from damaging thesurgical implant 600. FIG. 25B shows the elastic rings 606 and 608 instretched states.

FIGS. 26A-G illustrate an alternative embodiment of an implant assembly630 having a surgical implant 632 that is spaced away from and coupleswith soft tissue anchors 634, 636, 638, and 640 via filaments 642, 644,646, and 648. As will be discussed, the spacing of the soft tissueanchors 634, 636, 638, and 640 from the implant 632 can be adjusted totension the implant, and to allow the soft tissue anchors 634, 636, 638,and 640 to reach various target tissue regions in the patient'sretropubic space.

The depicted surgical implant 632 is similar to the surgical implant 70of FIG. 4, and the depicted soft tissue anchors 634, 636, 638, and 640are similar to the soft tissue anchor 570 of FIG. 23. More particularly,as shown in FIG. 26A, the filament 642 threads through a first aperture650 of the implant 632, through an aperture 652 in the anchor 634, andthrough a second aperture 654 of the implant 632. Two ends 642 a and 642b of the filament 642 are cinched by a slidable filament lockingmechanism 656 into an adjustable size loop. Similarly, the implant 632couples to the soft tissue anchor 636 via filament 644, filament lockingmechanism 660, and apertures 666, 668, and 670, to soft tissue anchor640 via filament 648, filament locking mechanism 662, and apertures 672,674, and 676, and to soft tissue anchor 638 via filament 646, filamentlocking mechanism 664, and apertures 678, 680, and 682. FIG. 26B showsthe implant 632 after anchoring the soft tissue anchors 634, 636, 638,and 640 to obturator membranes 639 and 641. Instead of filament lockingmechanisms 660, 662, 664, and 656, other adjustable cinching elementscan be used, such as slip knots.

The filaments 642, 644, 646, and 648 along with filament lockingmechanisms 660, 662, 664, and 656 allow an operator to adjustablytension the implant 632 within the pelvic region of the patient. Moreparticularly, once an operator delivers the implant 632 to a targettissue region, such as the obturator membranes as depicted in FIG. 26B,the operator tensions surgical implant 632 and/or adjusts its length orwidth using filament locking mechanisms 660, 662, 664, and 656 bydrawing implant corners 632 a, 632 b, 632 c, and 632 d towardsrespective anchors 634, 636, 638, and 640. In particular, as depicted inFIGS. 26C-D, an operator grasps a tensioning tool 700 with one hand andone or both filament ends 642 a and 642 b with another hand. Thetensioning tool 700 includes a handle 700 a, a shaft 700 b extendingdistally from the handle, and a curved, looped, or hooked tip 700 c at adistal end of the shaft 700 b oriented at an angle to the shaft 700 b.The tip 700 c of the tensioning tool 700 is sized and shaped to hookonto and engage with the filament locking mechanism 656 and to slide thefilament locking mechanism 656 along the filament 642 to adjust thedistance from the implant corner 632 a to the anchor 634 (secured to atarget tissue region) and thereby tension and/or adjust the lengthand/or width of the implant assembly.

In an exemplary technique, the operator abuts the tip 700 c of thetensioning tool 700 against the proximal end 656 a of the filamentlocking mechanism 656. The filament locking mechanism 656 may beexternal to the patient, within the vaginal canal, or beyond the vaginalincision and within the pelvic region of the patient. When the filamentlocking mechanism 656 is beyond the vaginal incision, the operatorinserts the tensioning tool 700 through the same vaginal incision. Next,as shown in FIG. 26D, the operator pushes the tensioning tool 700 in adistal direction 706 towards the implant corner 632 a while pulling oneor both filament ends 642 a and 642 b in a proximal direction 708 awayfrom the implant corner 632 a. The filament ends 642 a and 642 b may lieexterior to the patient, within the vaginal canal, or beyond the vaginalincision. If the filament ends 642 a and 642 b are inaccessible by hand,the operator may use forceps or other suitable instruments to grasp thefilament ends 642 a and 642 b. The filament locking mechanism 656 thenslides in a distal direction 706 along the filament 642 and towards theimplant corner 632 a. In certain embodiments, the filament lockingmechanism 656 is configured to slide in one direction (i.e., distally706) and not in a retrograde direction (i.e., proximally 708). The samemay apply if slip-knots are used (i.e., the slip knots may be one-wayslip knots).

The filament locking mechanism 656 then abuts against implant corner 632a and draws implant corner 632 a towards the anchor 634 which increasesthe tension of the implant 632. FIG. 26E depicts the implant corner 632a, the anchor 634, the filament locking mechanism 656, and the filament642 after such an exemplary tensioning technique. The operator thenrepeats this process for implant corners 632 b, 632 c, and 632 d untilthe implant 632 is properly tensioned. FIG. 26F depicts the implant 632after the operator has tensioned all four corners 632 a-d. While thedepicted implant 632 couples to four anchors at respective corners 632a-d, the implant 632 may also couple to anchors at sides or edges of theimplant 632 that are spaced away from the corners 632 a-d.

The operator can also loosen the implant 632 using filament lockingmechanisms 660, 662, 664, and 656. An exemplary technique is depicted inFIG. 26G, in which an operator grasps the tensioning tool 700 and abutsthe tip 700 c against the proximal end 656 b of the filament lockingmechanism 656. The operator pulls the tensioning tool in a proximaldirection 708, and as a result the filament locking mechanism 656 slidesproximally along the filament 642. The implant corner 632 a is then freeto slide in a proximal direction 708 along the filament 642. Theoperator then repeats this process for implant corners 632 b-d until theimplant 632 is properly loosened to a desired tension.

Although the depicted tensioning and loosening technique was describedin connection with the anchors 634, 636, 638, and 640 anchoring torespective obturator membranes 639 and 641, the anchors 634, 636, 638,and 640 can also couple to other target tissue regions in the patient'sretropubic space. For example, in one alternative implementation, theanchors 634 and 636 anchor to target tissue regions of the patient'ssacrospinous ligament or levator ani muscle, while the anchors 638 and640 anchor to target tissue regions of the patient's obturator membranes639 and 641.

Having described various exemplary surgical implants, and systems andmethods for anchoring the implants within the patient and tensioning theimplants once the implants are anchored, various exemplary devices arenow described for use in inserting the surgical implants through asingle vaginal incision. In certain embodiments, the delivery devicesinclude a handle and a shaft extending distally from the handle tocouple with a soft tissue anchor. In certain configurations, thedelivery devices include movable parts that allow an operator to controlthe release of the soft tissue anchor from the delivery device, measurethe delivery location of the soft tissue anchors, and/or measureappropriate lengths of an implant for use in a particular patient. Thedelivery devices are generally shaped so that an operator can guide adistal end of the delivery device through the patient's vaginal opening,through the vaginal incision, and towards a patient's obturatormembrane. In certain embodiments, the delivery device is also shaped toextend through the vaginal incision to the contra-lateral obturatormembrane, and in others the operator is provided with a second devicehaving an opposite curvature to extend through the vaginal incision andto the contra-lateral obturator membrane. In certain exemplarytechniques, soft tissue anchors secure the implant to target tissueregions, whereas in others, tanged portions of the implant secure theimplant to the target tissue regions.

More particularly, FIG. 27 shows a delivery device 800 for delivering aimplant assembly to the pelvic region of a patient. The delivery device800 includes a handle 802, a cannula 804 extending distally from thehandle 802, and a movable shaft 806.

The handle 802 includes a proximal end 808 and a distal end 810. Thehandle 802, as depicted, is substantially straight and tapers inwardfrom the proximal end 808 to a distal location 812. The distal portion810 of the handle 802 tapers outward from the distal location 812 toprevent a medical operator's hand from slipping distally while graspingthe handle 802.

The cannula 804 has a proximal end 804 a and distal end 804 b, andextends distally from a distal most end 814 of the handle 802. Thecannula 804 is substantially straight, but this need not be the case. Inalternative embodiments, it may include any combination of curvedsections and straight sections, and may extend into one, two or moreplanes. The shaft 806 interfits within the cannula 804 and mechanicallycouples at a proximal end to a slider 816 on/within the handle 802. Anoperator may slide the slider 816 axially within the slot to retract andextend the shaft 806 in and out of the cannula 804. With the shaft 806extended, a distal most end 820 of the cannula 804 forms a shoulder 822.

In operation, an operator slides the slider 816 distally and therebyextends the shaft 806 to an extended position. Next, the operatorinterfits a tissue anchor, such as the tissue anchors described above,onto the distal end of the shaft 806. The operator then inserts thedistal end of the delivery device 800 with the tissue anchor into thebody of the patient, for example, via the incision in the vaginal wallaccording to the illustrative procedure. The operator advances thedevice until the anchor is placed at a target tissue region such as anobturator membrane. Next, the operator retracts the slider 816 toretract the shaft 806 into the cannula 804 and out of the tissue anchor.In certain implementations, the tissue anchor abuts against the shoulder822 of the delivery device 800 and thereby disengages from the shaft 806when the shaft 806 retracts into the cannula 820. The operator removesthe delivery device 800 from the patient and thereby leaves the tissueanchor placed and anchored at the target tissue region. The anchor maybe coupled to an implant that is coupled to one or more other softtissue anchors. The operator may repeat the procedure for the other softtissue anchors with the same or a different delivery device.

According to the illustrative embodiment, when the shaft 806 is in anextended position, the exposed distal section of the shaft 806 isbetween about 2 centimeters and about 4 centimeters long. In otherillustrative embodiments, it is between about 1 centimeter and about 3centimeters long. In further illustrative embodiments, the narroweddistal section of the shaft 806 has an outside diameter of between about0.03 inches and about 0.05 inches. In one illustrative embodiment, ithas an outside diameter of about 0.04 inches. According to otherconfigurations, the outside diameter of the cannula 804 at the distalend 820 is between about 0.07 inches and about 0.1 inches. In oneimplementation, the outside diameter of this portion of the cannula isabout 0.09 inches. According to one configuration, the total distancefrom the distal end 814 of the handle 802 to the distal most tip 806 aof the shaft 806, with the shaft extended is between about 7 centimetersand about 20 centimeters. In other configurations, the total distance isbetween about 8 centimeters and about 12 centimeters.

Alternatively, delivery devices may include a fixed shaft and a movablecannula disposed about the fixed shaft. FIG. 28 shows such a deliverydevice 900 and an implant assembly 920. The delivery device 900 includesa handle 902, a needle/shaft 910 extending distally from the handle 902,a pusher button 904 distal to the handle 902, and a cannula 906 disposedabout the shaft 910 and extending distally from the pusher button 904.

The shaft 910 is generally linear at its proximal end 910 a, and curvestowards its distal end 910 b. However, in other embodiments the shaft910 may be straight, may include any combination of curved sections andstraight sections, and/or may extend into one, two or more planes. Wheninserting the delivery device 900 through the vaginal incision andtowards an obturator membrane, a straight shaft may facilitate accessfor an operator to more posterior regions of an obturator membrane,whereas a shaft with more curvature may facilitate access to moreanterior regions of an obturator membrane. In certain embodiments, theshaft may be shorter in length than the depicted shaft 910 which mayprovide an operator with better control. In certain embodiments, theshaft 910 has a diameter of between about 0.075 inches and about 0.2inches, and in certain embodiments is about 0.107 inches. The shaft 910includes a tip 916. The tip 916 can be sharp and suited to incise and/ordissect human tissue, or blunt and suited for blunt dissection and/ordilation of human tissue. In certain embodiments, the tip is blunt so asto avoid damaging sensitive structures such as organs, nerves, andarteries, as will be discussed below.

The pusher button 904 comprises polymeric materials and is mechanicallycoupled to the cannula 906. The cannula 906 is shorter in length thanthe shaft 910, and when the button 904 is in a retracted state, asdepicted in FIG. 28, the shaft 910 is exposed at its distal end 910 b.In certain implementations, the exposed portion of the shaft 910 isslightly longer than about half the length of the implant assembly 920so the implant assembly 920 remains external to the body during initialplacement of the shaft 910.

The implant assembly 920 includes an implant 928 and anchors 926 and 922coupled to the implant 928. The anchors 926 and 922 are similar toanchor 560 of FIG. 22A, but can be similar to any of the anchorsdescribed herein. The anchors 926 and 922 include respective axialthrough holes. The inner diameter of the anchor 926 is preferably sizedand shaped to fit around and slide against the outer diameter of theshaft 910. The anchor 926 slides proximally along the shaft 910 andabuts the distal end of the pusher cannula 906. The outer diameter ofthe anchor 926 can be smaller, larger, or equal to the outer diameter ofthe pusher cannula 906. The implant 928 further includes a center mark924 indicating the center, or “half-length,” of the implant 924. In oneusage of device 900, the center mark 924 of the implant is placeddirectly underneath the urethra. However, in other implementations,device 900 is used with larger meshes that include marks which areplaced under other anatomical structures, such as, for example, the baseof the bladder.

The cannula 906 includes a pusher mark 908 that indicates where thecenter mark 924 of the implant 928 will be positioned after the implant928 has been placed using the delivery device 900. In one exemplary modeof operation, when an operator delivers the implant 928 using thedelivery device 900 with the pusher button 904 and the cannula 906retracted, the operator positions the pusher mark 908 underneath theurethra such that when the operator advances the pusher, the center mark924 of the implant 928 lies about or directly underneath the urethra.However, in embodiments wherein implants include marks indicatingplacement of the implant with respect to another anatomical structure,such as the base of the bladder, the operator accordingly positions thepusher mark 908 underneath that anatomical structure.

In operation, an operator couples an anchor 926 of the implant assembly920 to the shaft 910. The anchor 926 slides proximally along the shaft910 and abuts the distal end of the pusher cannula 906. The operatorinserts the shaft 910 into the body of the patient and guides the tip916 towards a target region while the button 904 is retracted. Incertain implementations, the operator advances the tip past the targetregion. The operator optionally gauges his proximity to the targetregion buy aligning the cannula mark 924 with an anatomical landmarksuch as the urethra. The operator advances the button 904 distally, andthereby advances the distal end of the cannula 906 towards the tip 916of the shaft 910. FIG. 29 shows the delivery device 900 of FIG. 28 withthe pusher 904 in an extended state. As will be described below, incertain implementations the operator advances the anchor 926 to a targetregion with the anatomy of the patient without pushing the anchor 926off of the shaft 910. Instead, after placement of the anchor 926, theoperator retracts the device 900 in a retrograde direction, whichdecouples the anchor 926 from the shaft 910.

In addition to the cannula mark 908, the device 900 may include othermarks that guide the operator. In order to measure how far to advancethe button 904 and cannula 908, in certain embodiments the shaft 910includes increment/measurement markings 910 a. The operator can use themeasurement markings to gauge the distance from the tip 916 of the shaftto the distal end of the cannula 908. FIG. 30 shows an alternate view ofthe device 900 of FIG. 29 with increment markings 910 a etched into theshaft 910. The markings 910 a can be disposed using other methods, suchas disposing a biocompatible ink or stain on the shaft 910.

As described above, the exemplary meshes, anchors and delivery devicesaccess target soft tissue regions, such as the obturator membranes, viasingle vaginal incisions. Exemplary surgical techniques for implantingthe meshes will now be described. As illustrated herein, the procedurecan be applied with meshes that are configured to support the urethra orbladderneck for the treatment of UI, and also with meshes that havelonger anterior-to-posterior widths for supporting the bladder, uterus,and/or other organs located within the patient's pelvic region.

FIG. 3A illustrates an exemplary single vaginal incision procedure forusing delivery device 900 to deliver an implant assembly 981 for thetreatment of a pelvic floor disorder. The exemplary implant assembly 981is similar to implant assembly 630 of FIG. 26A, and in particularincludes an implant 980 similar to implant 632 of FIG. 26A. The implantassembly 981 also includes three soft tissue anchors 982, 984, and 986on one side of the implant, and three soft tissue anchors 988, 990, and992 on a contralateral side. The anchors 982, 984, 986, 988, 990, and992 are similar to anchor 500 of FIG. 21A, and couple to the implant 980using filaments and filament locking mechanisms similar to thosedescribed in connection with FIG. 26A.

In the exemplary technique, the patient is placed on an operating tablein a position to provide access to the pelvic region. The operator maysubject the patient to local anesthesia, regional anesthesia, and/orgeneral anesthesia or sedation according to his preference. Next, theoperator makes a transverse incision (not shown) in the anterior vaginalwall of the patient and dissects the incision bilaterally according tohis preference using, for example, surgical scissors. In certainimplementations, the operator dissects bilaterally to the inferior pubicramus on both sides of the patient. The operator then identifies a pathof delivery of the implant by palpating tissue of the pelvic region. Theoperator may palpate by inserting his finger through the vaginalincision and may identify anatomical structures such as the obturatorforamen.

Next, the operator accesses the patient's pelvic region via the singleincision to insert the implant into the patient's pelvic region andsecure the implant within the region so that at least a portion of theimplant is located posterior to the bladderneck. To accomplish this, theoperator first couples anchor 982 to the tip 916 of the shaft 910,inserts the distal end of the shaft 910 into the body through theexternal vaginal opening 987 and then guides the distal end of the shaft910 through the vaginal incision towards an obturator membrane 950. Theoperator may palpate during delivery as preferred. The operator may alsouse the posterior portion of the patient's pubic bone as an anatomicallandmark to assist in guiding the needle. The operator optionallysecures the implant 980 against the shaft 910 during delivery so thatthe implant 980 does not obstruct the operator's vision or the path ofdelivery using any suitable sterile securing means, such as a sterileelastic band or tie.

The operator then punctures the obturator membrane 950 with the tip 916but stops short of extending a portion of the tip 916 or shaft 910through the surface of the patient's skin in the groin. The location ofthe puncture within the obturator membrane 250 depends on the anchorbeing delivered. For example, the operator delivers anchor 982 through asufficiently posterior region 950 b of the obturator membrane 950 sothat the implant assembly 981 extends to posterior regions of thepatient's pelvic floor and provides posterior support, while he deliversanchor 986 through an anterior region 950 a of the obturator membrane950 so that the implant assembly 981 extends to and supports anteriorregions of the patient's pelvic floor (e.g., so that at least a portionof the implant 981 extends to a location that is posterior to thepatient's bladder neck). In certain implementations, the operatorgenerally delivers the implant 980 along a path that avoids certainpelvic structures, such as the internal pudendal artery, the pudendalcanal, the perineal nerve, the labial nerve, and other vascular andnerve structures.

The operator may hear and/or feel a pop indicating that he has piercedthe obturator membrane 950. The operator gauges the length from thevaginal incision to the obturator 950 by using the markings orindications (not shown) on the shaft 910, by using the mark 908 (notshown in this figure) on the cannula 906, and/or by visually gauging thelength from the proximal edge of the anchor 982 to the vaginal incisionto assure that the length of the implant 980 is suitable for thepatient. As mentioned above, in certain implementations, the implant 980includes a visual marking that the operator places under a predeterminedanatomical landmark, such as the urethra or the bladder.

If needed, the operator further advances the shaft 910 to be near,contact, apply pressure to, poke (“tent-up”), or, in certain uses,pierce the epidermis (not shown) just beyond the obturator membrane 950,without penetrating entirely through the skin, until the shaft 910 is inan appropriate position to deliver the anchor 982. The operator mayexternally palpate the epidermis proximal to the obturator membrane tofeel the shaft 910 poke the epidermis and, confirm its location. Incertain embodiments the operator stops extending the tip 916 when itreaches a position that is beneath the patient's stratum corneum, whilein other embodiments the operator stops the tip 916 from extending tothe epidermis. In certain embodiments the operator stops the tip 916 inthe subcutaneous tissue or beneath the subcutaneous and does not extendthe tip 916 to the dermal layer.

In certain implementations, the incision is made in the vagina so as toallow the inserted shaft to be near, contact, apply pressure to, or pokethe skin at a position that is generally in line with the urethralmeatus. The operator anchors the anchor 982 to the obturator membrane,and retracts the shaft 910, thereby decoupling the shaft 910 from theanchor 982, using methods discussed above.

The operator repeats this process for anchors 984 and 986, in eachinstance delivering the anchors through the same vaginal incision. Next,the operator repeats the process on the contralateral side, deliveringanchors 988, 990, and 992 to the obturator membrane 951 through the samevaginal incision. The operator also inserts the region 981 of theimplant 980 through the vaginal incision. In certain implementations theregion 981 is inserted after the operator inserts the anchors 982, 984and 986 on one side of the patient but before inserting anchors 988, 990and 992 on the other side. Once all of the anchors 982, 984, 986, 988,990, and 992 are delivered through the vaginal incision in the anteriorvaginal wall and extended to respective obturator membranes 950 and 951,the entire implant 980 will have been delivered through the vaginalopening 987 and through the vaginal incision, and thus lie in a regionanterior to the vaginal canal and supporting the urethra, bladder,and/or bladderneck.

The order in which the operator delivers the anchors 982, 984, 986, 988,990, and/or 992 can vary. In certain implementations, the operatordelivers anchors in a posterior-to-anterior order so that anteriorportions of the implant do not obstruct or get in the way of theoperator when delivering posterior anchors. Although cystoscopies arenot required with the above-described procedure, the operator mayperform a cystoscopy to check for bladder damage after delivering any orall of the anchors. Also during delivery, the operator optionally uses apair of forceps or another suitable medical instrument to space theimplant 980 from the urethra (not shown) during delivery of one or moreof the anchors to prevent excessive tension or stress on the urethra.When completed, the operator reviews the implant 980 to confirm that itis properly placed under the organ needing support, then sutures thevaginal incision.

For certain patients, the lateral length of the implant 980 may belonger than the obturator-to-obturator length of that patient. In thesecases, the operator may leave equal lengths of the implant displaced onexternal sides of the obturator membranes 950 and 951. By way ofexample, if the implant 980 has a lateral length of about 10 cm, thenthe patient with obturator to obturator length of about 7 cm will haveabout 1.5 cm of implant displaced on each side beyond the obturatormembranes 950 and 951. Alternately, the manufacturer can supply implantswith various lateral lengths to suit various patients.

The device 900 and a similar delivery technique can be used to delivernon-woven implants discussed above (i.e., implant 140 of FIG. 7A),and/or implants that do not extend to posterior regions of the patient'sanatomy and are instead sized and shaped for treating urinaryincontinence. FIG. 31B illustrates the use of device 900 to deliver animplant 994 with a narrower anterior-to-posterior width 994 a that isdesigned to underlie and support the urethra and/or bladderneck of thepatient. The implant 994 is directly coupled to anchors 500 of FIG. 21A.The operator uses a delivery method similar to that described inconnection with FIG. 3A, except that the operator only delivers two softtissue anchors 500. In any event, the operator extends the soft tissueanchors 500 within the patient's soft tissue but stops short ofextending a portion of the device through the surface of the patient'sskin, as described above.

The surgical methods described above are non-limiting examples. Otherswill be apparent upon review of this disclosure. In certain alternativeimplementations, devices used to insert the implants are set forth inFIGS. 32A-34B. FIGS. 32A-C shows another illustrative delivery device1060 that is sized and shaped for transobtural placement of animplantable implant through the single vaginal incision, and employable,without limitation, with any of the illustrative embodiments describedherein. More particularly, the delivery device 1060 includes a handle1062 with first 1062 a and second 1062 b substantially straight sectionslocated substantially in a first plane and angled relative to eachother, a transitional portion 1065 extending out of a distal end 1063 ofthe handle 1062 which interfits and extends axially out of the distalend 1063 of the second straight handle section 1062 b, and a halo-shapedcurved shaft 1064 extending from a distal end of the transitionalportion 1065. The curved shaft 1064 includes a reduced diameter section1064 a at a distal end of the shaft 1064 and an increased diametersection 1064 b at a proximal end of the shaft 1064. The increaseddiameter section 1064 b and the reduced diameter section 1064 a adjointo form a shoulder/ledge 1064 c. In use, an operator couples a softtissue anchor to the device 1060 by interfitting the reduced diametersection 1064 a of the shaft 1064 through a through-aperture of the softtissue anchor. The increased diameter section 1064 should have across-section with a larger diameter than the diameter of thethrough-aperture, and thus the shoulder 1064 c provides a mechanicalstop that prevents the anchor from sliding proximally along the shaft1064. In certain embodiments, the increased diameter section 1064 b andthe reduced diameter section 1064 a are manufactured from a unitarybody. However, in other embodiments, the increased diameter sectioncomprises a flexible sheath or covering that an operator slides over thereduced diameter section 1064 a and around the shaft 1064.

In this embodiment, the first substantially straight section 1062 a hasa longitudinal axis 1067 that is normal to the plane of the curved shaft1064. However, the longitudinal axis 1067 can form any suitable anglewith respect to the plane of the curved shaft (e.g., about 10, 20, 30,45, 60, 70 or 80 degrees). By way of example, FIGS. 33A-B show twosymmetric devices 1040 and 1041 similar to device 1060 of FIGS. 32A-C,but having alternative flat handles 1043, tapered tips 1046 a at distalends of the curved shafts 1046, and having longitudinal axes 1042 thatform angles 1044 of about 60 degrees with respect to the planes of thecurved shafts 1046.

FIG. 34A shows an exemplary technique for delivering an implant usingdevice 1041. The implant 1120 is similar to implant 30 of FIG. 2A,except that implant 1120 includes a central region 1120 a that isrectangular rather than trapezoidal. Anchors 1122, 1124, 1126, 1128,1130, and 1132, similar to anchor 500 of FIG. 2A, directly couple tostraps 1120 b, 1120 c, 1120 d, 1120 e, 1120 f, and 1120 g of implant1120.

In the exemplary technique, first the patient is placed in a position toprovide access to the pelvic region. The operator may subject thepatient to local anesthesia, regional anesthesia, and/or generalanesthesia or sedation according to his preference. Next, the operatormakes a transverse incision (not shown) in the anterior vaginal wall ofthe patient and dissects the incision bilaterally according to hispreference using, for example, surgical scissors. In certainimplementations, the operator dissects bilaterally to the inferior pubicramus on both sides of the patient. The operator then (optionally)identifies a path of delivery of the implant by palpating tissue of thepelvic region. The operator may palpate by inserting his finger throughthe vaginal incision and may identify anatomical structures such as theobturator foramen.

Next, the soft tissue anchor 1122 is interfitted over the tapered tip1046 a (not shown in this figure) of the delivery device shaft 1064. Theoperator grasps the handle 1043 and inserts the delivery device shaftportion 1046 with the anchor 1122 through the vaginal incision. With alateral motion, the medical operator passes the curved shaft 1046 behindthe ischiopubic ramus 1140 and pierces the obturator membrane 1142.

The delivery device shaft 1046 is then withdrawn through the vaginalincision with a retrograde motion by the operator, leaving the anchor1122 implanted in or through the obturator membrane 1142 and,optionally, fixed to the obturator membrane 1142 as described above. Theoperator implants the anchor 1122 in a sufficiently posterior region1142 a of the obturator membrane 1142 so that the implant 1120 providessupport to posterior anatomical structures and regions, such as the baseof the bladder, in each instance delivering the anchors through the samevaginal incision.

This process is repeated for anchors 1124 and 1126. Next, the process isrepeated for anchors 1128, 1130, and 1132 to the contralateral obturatormembrane 1146 with the same or a second delivery device (i.e., thesymmetric delivery device 1040 with opposite shaft 1064 curvature). Asdescribed above in connection with other exemplary techniques, theoperator can perfoini cystoscopies during the procedure to check forbladder damage.

The halo-shaped curved shaft 1046 is beneficial at least in part in thatthe operator can navigate the tip 1046 a about the ischiopubic ramuswith lessened movement of his arm, wrist, and/or hand to provide a moreaccurate placement of the anchors. The operator may palpate duringdelivery as preferred. The operator may also use the posterior portionof the patient's pubic bone as an anatomical landmark to assist inguiding the needle. The halo-shaped curved shaft 1046 is also beneficialin part because it is shaped to avoid sensitive nerves and vascularstructures that may be located in or near certain regions of theobturator membrane 1142. In some patients, these sensitive structuresare more concentrated in superior regions of the obturator membrane1142. Thus, in certain implementations, the operator delivers theanchors 1122, 1124, 1126, 1128, 1130, and 1132 to regions in thevicinity of the obturator membranes 1142 and 1146 that are proximal toinferior pubic bone structures, such as the inferior ramus of the pubisand the ramus of the ischium.

As was the case with delivery device 900, delivery devices 1040, 1041,and 1060 can be used to deliver non-woven implants discussed above(i.e., implant 140 of FIG. 7 a), and/or implants that do not extend toposterior regions of the patient's anatomy and are instead sized andshaped for treating urinary incontinence. FIG. 34B illustrates the useof device 1041 to delivery a mesh implant 1048 with a relatively narrowanterior-to-posterior width 1048 a that is designed to underlie andsupport the urethra and/or bladderneck of the patient. The operator usesa delivery method similar to that described in connection with FIG. 34A,except that the operator only delivers two soft tissue anchors 500coupled to the implant 1048. Additionally, the device 1041 includes analternative handle configuration 1043 a that includes grooves to providethe operator with a better grip of the device 1041.

FIG. 31A-B and FIGS. 34A-B illustrate exemplary techniques fordelivering implants that are secured to respective obturator membraneswith soft tissue anchors. However, as mentioned above, in certainembodiments the implants are secured directly to target tissue regionsof the retropubic space using tangs that are of unitary body with theimplant. FIGS. 35A-B depict exemplary tanged implants and techniques fordelivering and securing the implants.

In the exemplary techniques involving soft tissue anchors discussedabove in connection with FIGS. 3A-B and FIGS. 34A-B, the implant couplesto soft tissue anchors, which are then coupled to a delivery device.However, when no soft tissue anchors are used, the implant couplesdirectly to the delivery device. FIG. 35A depicts an implant 1102directly coupled to the delivery device 1060 that was shown in FIGS.32A-32C. The implant 1102 includes tanged portions 1104 a and 1104 b atrespective ends of the implant 1102, and a non-tanged portion 1104 cbetween the tanged portions 1104 a and 1104 b. The tanged implant 1102can be manufactured using a technique similar to that described inconnection with the tanged implant 30 of FIG. 2B.

In use, the operator couples the implant 1102 directly to the deliverydevice 1060 by sliding the reduced diameter portion 1064 a through oneof the interstices 1110 of the implant 1102. In order for the reduceddiameter portion 1064 a to fit through one of the interstices, incertain embodiments the reduced diameter portion 1064 a has a diameterof less than about 1 mm. The operator then follows the same steps asthose described in connection with FIG. 34B to guide the distal end ofthe delivery device 1060 to the obturator membrane 1112 b. However,instead of piercing a soft tissue anchor through the obturator membrane,the operator drives the reduced diameter portion 1064 a of the device1060 with at least part of the tanged portion 1104 b through theobturator membrane 1112 b. The delivery device 1060 is then withdrawnthrough the vaginal incision leaving the tanged portion 1104 b implantedin or through the obturator membrane 1112 b. The operator then repeatsthis process to anchor the contra-lateral tanged portion 1104 a to thecontra-lateral obturator membrane 1112 a.

The tanged implant 1102 is sized and shaped to treat urinaryincontinence by supporting the patient's urethra and/or bladderneck.Tanged implants can also be used for treating other pelvic floordisorders. FIG. 35B shows an oblique view of the pelvic region 1128 of apatient with an implant 1130 similar to the implant 30 of FIG. 2, buthaving tanged straps 1130 a-f. To deliver the implant 1130, the operatoruses a similar method as that described in connection with FIG. 35A todeliver each of the tanged ends 1130 a-c to a first obturator membrane1132 and to then deliver each of the tanged straps 1130 d-f to acontra-lateral obturator membrane 1134.

As noted above, after placing a surgical implant, the operator tensionsthe implant to provide the proper support to anatomical structures ofthe pelvic region using methods described above.

In addition to the obturator membranes, in certain alternativeimplementations an operator anchors the implant to other anatomicalstructures. These structures include posterior or lateral tissues ormuscles, such as the sacrospinous ligament and the levator ani muscle.The sacrospinous ligament is a thin and triangular tissue that isattached by its apex to the spine of the patient's ischium, andmedially, by its broad base, to the lateral margins of the sacrum andcoccyx in front of the sacrotuberous ligament. The sacrospinous ligamentis a convenient location to anchor mesh straps in the posterior regionsof the pelvic floor in order to provide posterior support. The levatorani muscle is a broad, thin muscle situated generally on the side of thepelvis that is attached to the inner surface of the lesser pelvis. It isa convenient location to anchor mesh straps in order to provide lateraland/or posterior support and tension for a surgical implant.

More particularly, FIG. 36 shows an exemplary position of a surgicalimplant 1142 in the pelvic region 1140 of a patient. The implantincludes three sets of straps. The anterior set of straps 1142 a-banchor to respective obturator membranes as discussed above inconnection with other exemplary implant positions, and provide anteriorsupport to the implant 1142. The lateral set of straps 1142 b-c anchorto respective target tissue regions 1144 a and 1144 b about thetendinous arch of the levator ani muscle and provide lateral support tothe implant 1142. The posterior set of straps 1142 e-f anchor torespective target tissue regions 1146 a and 1146 b of the sacrospinousligament and provide posterior support to the implant 1142. Each of thestraps 1142 a-f anchors to a respective target tissue region via a softtissue anchor 500 discussed in connection with FIG. 21A. However, inother embodiments the straps 1142 a-f have tangs that anchor torespective target tissue regions.

One exemplary implantation technique is performed in three phases. In afirst phase, the operator inserts and secures the posterior straps 1142e-f into the sacrospinous ligament. In a second phase, the operatorinserts and secures the lateral straps 1142 c-d into the levator animuscle. In a third phase, the operator inserts the anterior straps 1142a-b through the obturator foramen and secures the straps in eitherobturator membranes or in the patient's tissues proximal to theobturator canals.

More particularly, in the first phase, to insert the strap 1142 e, amedical operator creates an incision in a patient's anterior vaginalwall 1148. The incision can be dissected or extended as required tofacilitate access of a delivery device to target region 1146 b. Next,the operator couples, preferably external to the body, mesh strap 1142 ewith delivery device 900 described above in connection with FIG. 28 viathe soft tissue anchor 500 (not shown) described in connection with FIG.2A.

The operator then inserts the device 900 and the coupled mesh strap 1142e through the vaginal opening, into the vaginal canal, and through thevaginal incision. The operator guides the tip 916 of the device towardsthe target region 1146 a of the sacrospinous ligament, and pierces anddrives the mesh strap 1142 e through the target region 1146 a. Theoperator then retracts the device, leaving the strap 1142 e anchored tothe target region 1146 a. For strap 1142 e, as well as the other straps1142 a-d and 1142 f, the operator may use other devices having varyingshaft lengths and curvatures in order to reach the appropriate targettissue region via the vaginal incision.

The operator then delivers the mesh strap 1142 f through the vaginalopening and through the vaginal incision in a similar manner as 1142 e.The vaginal incision may be dissected or extended as necessary tofacilitate access of delivery device 900 to target region 1146 b. Theoperator may use the same delivery device 900 for delivery of strap 1142f, or alternatively may use a second delivery device 900.

In the second phase, the operator inserts the straps 1142 d-e intotarget regions 1144 a and 1144 b of the levator ani muscle. To insertstrap 1142 c, the operator first couples delivery device 900 to the meshstrap 1142 c using a soft tissue anchor 500, then inserts the device 900into the vaginal canal, and through the vaginal incision. The operatorthen pierces and drives the mesh strap 1142 c through the target region1144 a of the levator ani muscle, and retracts the delivery device 900using methods discussed above. The operator similarly delivers meshstrap 1142 d to target region 1144 b of the tendinous arch of thelevator ani muscle contra-lateral to target region 1144 a using deliverydevice 900.

In a third phase, the operator inserts the anterior straps 1142 a and1142 b through the obturator foramen and secures the straps torespective obturator membranes or to the patient's tissues proximal theobturator canals using any of the exemplary methods and devicesdiscussed above.

In alternative embodiments, the implants can be stitched or sutured tothe target tissue regions. Moreover, the operator may use any operativecombination of the above-described techniques. For example, the operatormay anchor any of the implants described herein on one side of thepatient's retropubic space using soft tissue anchors, while anchoringthe same implant to the contra-lateral side of the patient's retropubicspace using tanged portions of the implant.

According to another feature, the implants of the invention may includeany suitable end portions, such as tissue dilators, anchors, andassociation mechanisms for associating the implant with the deliverydevices of the invention. The implants and other features describedherein may be adapted for use in multi-incision procedures, such as, forexample, US 2005/0245787, 2005/0250977, 2003/0220538, and 2004/0249473.They may also include other implants (i.e., slings), sling assemblies,sling delivery approaches, sling assembly-to-delivery device associationmechanisms, and sling anchoring mechanisms. These and other featureswith which the delivery devices, implants, methods, and kits of theinvention may be employed are disclosed in U.S. Pat. No. 6,042,534,entitled “Stabilization sling for use in minimally invasive pelvicsurgery,” U.S. Pat. No. 6,755,781, entitled “Medical slings,” U.S. Pat.No. 6,666,817, entitled “Expandable surgical implants and methods ofusing them,” U.S. Pat. No. 6,042,592, entitled “Thin soft tissuesurgical support mesh,” U.S. Pat. No. 6,375,662, entitled “Thin softtissue surgical support mesh,” U.S. Pat. No. 6,669,706, entitled “Thinsoft tissue surgical support mesh,” U.S. Pat. No. 6,752,814, entitled“Devices for minimally invasive pelvic surgery,” U.S. Ser. No.10/918,123, entitled “Surgical Slings,” U.S. patent application Ser. No.10/641,376, entitled “Spacer for sling delivery system,” U.S. patentapplication Ser. No. 10/641,192, entitled “Medical slings,” U.S. Ser.No. 10/641,170, entitled “Medical slings,” U.S. Ser. No. 10/640,838,entitled “Medical implant,” U.S. patent application Ser. No. 10/460,112,entitled “Medical slings,” U.S. patent application Ser. No. 10/631,364,entitled “Bioabsorbable casing for surgical sling assembly,” U.S. Ser.No. 10/092,872, entitled “Medical slings,” U.S. patent application Ser.No. 10/939,191, entitled “Devices for minimally invasive pelvicsurgery,” U.S. patent application Ser. No. 10/774,842, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/774,826, entitled “Devices for minimally invasive pelvic surgery,”U.S. Ser. No. 10/015,114, entitled “Devices for minimally invasivepelvic surgery,” U.S. patent application Ser. No. 10/973,010, entitled“Systems and methods for sling delivery and placement,” U.S. patentapplication Ser. No. 10/957,926, entitled “Systems and methods fordelivering a medical implant to an anatomical location in a patient,”U.S. patent application Ser. No. 10/939,191, entitled “Devices forminimally invasive pelvic surgery,” U.S. patent application Ser. No.10/918,123, entitled “Surgical slings,” U.S. patent application Ser. No.10/832,653, entitled “Systems and methods for sling delivery andplacement,” U.S. patent application Ser. No. 10/642,397, entitled“Systems, methods and devices relating to delivery of medical implants,”U.S. patent application Ser. No. 10/642,395, entitled “Systems, methodsand devices relating to delivery of medical implants,” U.S. patentapplication Ser. No. 10/642,365, entitled “Systems, methods and devicesrelating to delivery of medical implants,” U.S. patent application Ser.No. 10/641,487, entitled “Systems, methods and devices relating todelivery of medical implants,” U.S. patent application Ser. No.10/094,352, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/093,498, entitled “Systemfor implanting an implant and method thereof,” U.S. patent applicationSer. No. 10/093,450, entitled “System for implanting an implant andmethod thereof,” U.S. patent application Ser. No. 10/093,424, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/093,398, entitled “System for implanting animplant and method thereof,” and U.S. patent application Ser. No.10/093,371, entitled “System for implanting an implant and methodthereof,” U.S. Pat. No. 6,197,036, entitled “Pelvic FloorReconstruction,” U.S. Pat. No. 6,691,711, entitled “Method of Correctionof Urinary and Gynecological Pathologies Including Treatment ofIncontinence,” U.S. Pat. No. 6,884,212, entitled “Implantable Articleand Method,” U.S. Pat. No. 6,911,003, entitled “Transobturator SurgicalArticles and Methods,” U.S. patent application Ser. No. 10/840,646,entitled “Method and Apparatus for Cystocele Repair,” U.S. applicationSer. No. 10/834,943, entitled “Method and Apparatus for Treating PelvicOrgan Prolapse,” U.S. patent application Ser. No. 10/804,718, entitled“Prolapse Repair,” and U.S. patent application Ser. No. 11/115,655,entitled “Surgical Implants and Related Methods.” The entire contents ofall cited references are incorporated herein by reference in theirentirety. Variations, modifications, and other implementations of whatis described may be employed without departing from the spirit and thescope of the invention. More specifically, any of the method, system anddevice features described above or incorporated by reference may becombined with any other suitable method, system or device featuresdisclosed herein or incorporated by reference, and is within the scopeof the contemplated invention. All operative combinations between onedisclosed embodiment and any other embodiments are also contemplated. Itis intended that the scope of the invention be limited not by thisdetailed description but rather by the claims appended hereto.

The invention claimed is:
 1. A method of treating urinary incontinencein a patient, the method comprising: providing an implant comprising: amesh material having a first end, a second end, a central region, and aplurality of straps extending from the central region, and first andsecond anchors coupled to the mesh material; securing the first anchorto a first target tissue in a retropubic space of the patient; securingthe second anchor to a second target tissue in the retropubic space ofthe patient; and positioning the mesh material within the patient suchthat at least a portion of the mesh material is posterior to abladderneck of the patient, wherein securing the first and secondanchors includes the use of a delivery device comprising: a handlehaving a substantially straight proximal portion defining a first axisand a substantially straight distal portion defining a second axis, thesecond axis being at a first angle with respect to the first axis; and ahalo-shaped shaft extending from a distal end of the distal portion ofthe handle, the halo-shaped shaft being arranged in a plane that is at asecond angle with respect to the first axis and having an end sectionthat has an outer diameter that is less than an outer diameter of aproximal section of the halo-shaped shaft, the second angle beingdifferent than the first angle, the plane being perpendicular with thefirst axis, the proximal section being disposed between the end sectionand the distal portion of the handle, wherein the end section of thehalo-shaped shaft is configured to extend through an aperture defined ineach of the first and second anchors.
 2. The method of claim 1, whereinthe first and second anchors are soft tissue anchors.
 3. The method ofclaim 1, wherein the first and second anchors consist of a polymermaterial.
 4. The method of claim 1, wherein the first anchor and thesecond anchor each have at least one barb with a pointed tip.
 5. Themethod of claim 1, wherein the implant comprises tanged edges.
 6. Themethod of claim 1, further comprising a shoulder disposed at anintersection between the end section and the proximal section of thehalo-shaped shaft.
 7. The method of claim 6, wherein each of the firstand second anchors are configured to abut the shoulder during deliverythereof into the patient.
 8. The method of claim 1, wherein the plane isa first plane, the handle being arranged in a second plane that isdifferent than the first plane and perpendicular to the first plane. 9.The method of claim 1, wherein the outer diameter of the proximalsection of the halo-shaped shaft is substantially constant.
 10. Themethod of claim 1, wherein the implant comprises polypropylene.
 11. Themethod of claim 1, wherein the mesh material comprises a center mark.12. The method of claim 1, wherein the first target tissue comprises anobturator membrane.
 13. The method of claim 1, wherein the second targettissue comprises an obturator membrane.
 14. The method of claim 1,wherein the first target tissue comprises a levator ani muscle.
 15. Themethod of claim 1, wherein the second target tissue comprises a levatorani muscle.
 16. The method of claim 14, wherein the first target tissuecomprises a tendinous arch of the levator ani muscle.
 17. The method ofclaim 15, wherein the second target tissue comprises a tendinous arch ofthe levator ani muscle.
 18. A method of treating urinary incontinence ina patient, the method comprising: providing an implant comprising: amesh material comprising polypropylene and a center mark, and having afirst end, a second end, a central region, and a plurality of strapsextending from the central region, and a plurality of soft tissueanchors coupled to the mesh material; securing a first soft tissueanchor of the plurality of soft tissue anchors to a target tissue in aretropubic space membrane of the patient; securing a second soft tissueanchor of the plurality of soft tissue anchors to a second target tissuein the retropubic space of the patient; and positioning the meshmaterial within the patient such that at least a portion of the meshmaterial extends to a position posterior to a bladderneck of thepatient, wherein the securing the first and second soft tissue anchorscomprise the use of a delivery device comprising: a handle having asubstantially straight proximal portion defining a first axis and asubstantially straight distal portion defining a second axis, the secondaxis being at a first angle with respect to the first axis; and ahalo-shaped shaft extending from a distal end of the distal portion ofthe handle, the halo-shaped shaft being arranged in a plane that is at asecond angle with respect to the first axis and having an end sectionthat has an outer diameter that is less than an outer diameter of aproximal section of the halo-shaped shaft, the second angle beingdifferent than the first angle, the plane being perpendicular with thefirst axis, the proximal section being disposed between the end sectionand the distal portion of the handle, the end section of the halo-shapedshaft being configured to extend through an aperture defined in each ofthe first and second anchors.
 19. The method of claim 18, furthercomprising a shoulder disposed at an intersection between the endsection and the proximal section of the halo-shaped shaft.
 20. Themethod of claim 18, wherein the outer diameter of the proximal sectionof the halo-shaped shaft is substantially constant.
 21. The method ofclaim 18, wherein the plane is a first plane, the handle being arrangedin a second plane that is a different plane than the first plane andperpendicular to the first plane.